Clinical Trials
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Paediatrics
Cognitive Remediation in ADHD Children : Comparison Between Three Therapeutic Strategies : Cognitive Remediation With a Virtual Classroom Software and Methylphenidate and Supportive Psychotherapy (RECOGNITA)
Mar 2013The Attention Deficit Disorder with or without Hyperactivity (ADHD) is one of the most frequently found disorder in children. It is characterized by a triad of symptoms involving attention deficit, hyperactivity and impulsivity and having an impact on the functioning of the subject especially in terms of learning. Currently, main interventions to treat ADHD in children are stimulant medication or supportive psychotherapy. Data from recent studies highlight the use of stimulant drugs (amphetamine derivatives such as methylphenidate) to treat the core symptoms of ADHD children. These drugs are generally effective but their nature (psychostimulants) and adverse effects they cause (appetite suppression, sleep disturbances, headaches, motor tics, abdominal pain, irritability, nausea and fatigue) encourage the development of new therapeutic approaches. The use of supportive psychotherapy alone would have limited effect on symptoms of children with ADHD. Our aim is to test the use a cognitive remediation program using a virtual classroom in children suffering from ADHD.
NOPHO-DBH AML 2012 Protocol Research study for treatment of children and adolescents with acute myeloid leukaemia 0-18 years
Mar 2013The AML 2012 study is a treatment and research protocol with the overall aim of improving prognosis for children and adolescents with AML. This is to be achieved by better risk stratification based on MRD quantification and more intensive induction compared to previous NOPHO protocols. Specific research aims are 1) To investigate if DaunoXome® has a higher efficacy than Mitoxantrone, when given in course 1 for treatment of pediatric AML 2) To investigate if FLADx has a higher efficacy than ADxE when given as the second induction course for treatment of pediatric AML 3) To investigate the correlation between MRD measurement by PCR and flow cytometry and the prognostic impact of MRD with either method after course 1 and 2 respectively.
ICCM of Common Childhood Diseases: Mozambique and Uganda (inSCALE)
Mar 2013The aim of the inSCALE project is to test the effect of innovative approaches to increase coverage of integrated community case management, which provides community based-care for diarrhoea, pneumonia and malaria, resulting in more children receiving timely and appropriate care for these three most common childhood illnesses
Essential Fatty Acids in Adult ADHD (OCEAN-GER)
Feb 2013The aim of this project is to investigate the effect of a dietary supplementation with essential fatty acids in adults on cognitive functions related to attention and impulse control in the general population and in individuals with a diagnosis of attention deficit hyperactivity disorder (ADHD).
International Study for Treatment of Standard Risk Childhood Relapsed ALL 2010
Feb 2013The main goal of this study is to improve the outcome of children and adolescents with standard risk first relapsed acute lymphoblastic leukemia. Furthermore, goal is to set up a large international study group platform allowing for optimization of standard treatment strategies and integration of new agents.
Efficacy of Omega-3/Omega-6 Fatty Acids in Pre-school Children at Risk for ADHD
Feb 2013The efficacy of PUFAs (as nutritional supplement) in/for pre-school children with ADHS symptoms will be evaluated in a randomised controlled doubleblind trail with children aged 3-6 years.
The Effects of DHA on Attention Deficit and Hyperactivity Disorder (DADA)
Feb 2013The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in reducing Attention Deficit/Hyperactivity Disorder (ADHD) core symptoms in a clinical sample of children and adolescents with ADHD.
The More & Less Study: A Trial Testing Different Treatment Approaches to Obesity in Preschoolers (M&L)
Feb 2013Obesity has been shown to be resistant to treatment in adults, adolescents, and in school age children, but not during early childhood. Yet knowledge on the effectiveness of early childhood treatment programs for obesity is still very limited, preventing the widespread implementation of such programs. The overarching purpose of this study is to evaluate the effectiveness of early treatment of childhood obesity. The investigators plan to perform a carefully-designed randomized controlled trial that will evaluate different treatment options offered to families with children with obesity, organized within the healthcare system and followed up for at least 1 year post-baseline. Participants will be children aged 4-6 years (N=180) with obesity and their parents. This study will facilitate a close examination of key treatment components and mechanisms of change. Results from this study will lead to better healthcare options for obesity treatment during childhood and ultimately to the prevention of obesity later in life from a public health perspective.
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of Liraglutide in Obese Adolescent Subjects Aged 12 to 17 Years
Feb 2013This trial is conducted in Europe. The purpose of the trial is to assess safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of liraglutide in obese adolescent subjects aged 12 to 17 years.
Bone Microarchitecture in Young Cystic Fibrosis Patients
Feb 2013The aim of this study is to evaluate bone microarchitecture of paediatric CF patients matched to sex-age-pubertal status-healthy volonteers. In the meantime, biological markers will be collected and DXA (Dual-energy x-ray absorptiometry) will be performed in order to explore potential correlations HR-pQCT parameters.
Phase II Pharmacokinetics, Efficacy, and Safety of Belatacept in Pediatric Renal Transplant Recipients
Jan 2013The purpose of this study is to assess the pharmacokinetics (PK) efficacy and safety of Belatacept in stable pediatric renal transplant recipients.
Efficacy of KAM2904 Face Cream and KAM3008 Body Lotion Treatment in Children With Atopic Dermatitis (AD)
Jan 2013The main purpose of this study is to demonstrate the safety and efficacy of KAM2904 Face Cream and KAM3008 Body Lotion in reducing the symptoms of mild to moderate AD. Efficacy will be evaluated by comparing SCORAD and Eczema Area Severity Index (EASI) in a group of subjects treated with KAM2904 Face Cream and KAM3008 Body Lotion (the treatment group), versus a group of subjects treated with a petrolatum-based moisturizer (the control group). Safety will be determined by the number and severity of Adverse Events Device-Related.
Melatonin Dose-effect Relation in Childhood Autism (MELADOSE)
Jan 2013Melatonin is a neurohormone produced from serotonin which promotes sleep. The alterations in central and peripheral serotonin neurobiology and in circadian sleep-wake rhythms observed in autistic disorder suggest abnormalities in melatonin secretion. Several studies have reported a decrease in melatonin secretion in individuals with autism. Furthermore, nocturnal excretion of 6-Sulphatoxymelatonin (the predominant melatonin metabolite) was significantly negatively correlated with severity of autistic impairments in verbal communication and play. Melatonin could therefore have a therapeutic effect on sleep problems and may play a role in the pathophysiology of autistic disorder. These data highlight the possible therapeutic interest of an oral administration of melatonin in patients with autistic disorder. Thus, the objective of this clinical trial is to study the relation between the melatonin dose administered and its effect on severity of autistic impairments especially in verbal communication and play.
Closing the Loop in Children and Adolescents With Type 1 Diabetes in the Home Setting (APCam08)
Jan 2013Type 1 diabetes (T1D) is one of the most common chronic childhood diseases requiring lifelong insulin therapy. Children and adolescents with T1D need regular insulin injections or the continuous insulin delivery using an insulin pump in order to keep blood glucose levels normal. We know that keeping blood sugars in the normal range will help prevent longterm diabetes-related complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter we try to control blood glucose levels, the greater the risk to develop symptoms and signs of low glucose levels (hypoglycaemia). This is a particular problem at night and one solution is to develop a system whereby the amount of insulin injected is controlled by a computer and is very closely matched to the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed-loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives an insulin pump. We have been testing such a system in Cambridge over the last five years in children and have found that this system is effective at maintaining tight glucose control and preventing nocturnal hypoglycaemia. More recently the system has been tested in real life conditions in the home setting for three weeks during a pilot single-centre study. The next step is to extend the evaluation of closed-loop over a prolonged period of three months. In the present study we are planning to study 24 young people aged 6-18 years on insulin pump therapy. During three months glucose will be controlled by the computer and during the other three months the subjects will make their own adjustments to the insulin therapy. We aim to to determine the effect of the computer algorithm in keeping glucose levels between 3.9 and 8 mmol/L (normal levels) and reducing the time they spent with glucose below 3.9 mmol/L (hypoglycaemia). Participants' response to the use of the system in terms of lifestyle change, daily diabetes management and fear of hypoglycaemia will be assessed. We will also test for longer term glucose control by measuring glycated haemoglobin (HbA1c).
Osteosarcoma and Ewing Sarcoma Treatment Response Assessment With Functional MRI Imaging in Children and Young Adults (FUBEO)
Jan 2013The purpose of the study was to investigate whether functional MRI imaging (diffusion weighted imaging) is useful for monitoring the therapeutic response of bone sarcomas in children and young adults. All patients will be scanned before, during and after chemotherapy. The findings on MRI will be correlated with histological finding after surgery. Second purpose : to define apparent diffusion coefficient value of the bone sarcoma. Third purpose : to try define prognostic factors, to investigate if there is a correlation between early treatment response and outcome.
Omega-3 Fatty Acids Supplementation in ADHD
Jan 2013The overarching aim of the proposed study is to assess whether omega-3 fatty acids supplementation can augment the effects of methylphenidate in children with ADHD. The investigators hypothesized that omega-3 fatty acids supplementation will be associated with improved ADHD symptoms.
Efficacy Study of Topical Twice Weekly Fluticasone Treatment to Reduce Relapse in Atopic Dermatitis in Children
Jan 2013The main objective is to investigate long-term management (16 weeks) of AD with fluticasone propionate (FP) 0,05% cream twice weekly in addition to an emollient (vehicle) after stabilization of an acute flare of AD with FP cream.
Pharmacokinetics and safety of agomelatine in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with Major Depressive Disorder. An open-labelled, multicenter, three-dose level, non-comparative study.
Jan 2013The primary objective is to evaluate pharmacokinetics of 3 doses of agomelatine in patients from 7 to less than 18 years suffering from Major Depressive Disorder.
Determinants of Immunosuppressive Dose Requirements in Children After Solid Organ Transplantation
Jan 2013The long-term success of solid organ transplantation is largely dependent on the efficacy of immunosuppressive medication. Unfortunately, for the most important agents the correct drug levels are difficult to attain, with potential severe consequences of drug under- or overexposure. In addition there is a large variation in dose requirements within and between different subjects. Clinical studies have demonstrated that a better control of drug exposure can improve outcome. A large set of patient characteristics appear important in determining dose requirements in adults, in particular genetic variation in genes involved in drug metabolism. In children relative dose requirements are increased compared to adults, but is not known why and the role of pharmacogenetic variation has not been described. Our study aims to describe relative dose requirements in children after solid organ transplantation with the help of clinical and laboratory data obtained during regular hospital visits (retrospective). In addition we will assess their genotype for genes involved in the metabolism of immunosuppressives.
The Relationship of Essential Fatty Acids to Adult ADHD: The OCEAN Study (Oils and Cognitive Effects in Adult ADHD Neurodevelopment)
Dec 2012The aim of the study is to provide preliminary data on the relationship of Essential Fatty Acids (EFAs) to cognitive and electrophysiological measures of brain and behavioural functions in adults with attention deficit hyperactivity disorder (ADHD) and controls. This main aim will be achieved in two ways. First the investigators will measure the relationship of the various measures to blood levels of EFAs in ADHD cases and controls. Secondly, the potential effects of dietary supplementation with EFAs on cognitive-electrophysiological and behavioural measures in ADHD cases will be investigated. We will evaluate the extent to which changes in neuronal activity and cognitive performance are related to behavioural and functional measures over time. This is to be carried out by conducting a randomised controlled trial of fish oil supplementation in adults with ADHD (The OCEAN study: Oils and Cognitive Effects in Adult Neurodevelopment).
An open-label, multi-arm, non-comparative safety and tolerability study of canakinumab (ACZ885) in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA)
Dec 2012Part I: To evaluate the long-term safety and tolerability of canakinumab and to assess the retention rate of canakinumab treated patients Part II: To assess the long-term safety and tolerability of canakinumab
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
Nov 2012The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.
Emollients in the management of atopic dermatitis in children: prevention of flares.
Nov 2012To assess the ability of DEXERYL to prevent flares after treatment of a previous flare by a topical corticosteroid.
A Study of Decreased Dose Frequency in Patients With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab)
Nov 2012This open-label Phase IV study will evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of RoActemra/Actemra (tocilizumab) in reduced dose frequency in patients with adequately controlled systemic juvenile idiopathic arthritis who have experienced a laboratory abnormality on twice weekly RoActemra/Actemra dosing. Patients will receive RoActemra/Actemra 12 mg/kg or 8 mg/kg intravenously every 3 weeks. After 4 consecutive infusions, patients who experience an event of neutropenia, thrombocytopenia or liver enzyme abnormality will move to every 4 weeks RoActemra/Actemra administration. Anticipated time on study treatment is 52 weeks.
Relapse prevention in children and adolescents with DSM-IV-TR conduct disorder treated with risperidone: a randomised, double-blind, placebo-controlled discontinuation study.
Nov 2012The primary objective is to test the hypothesis that, after at least 16 weeks of daily administration (4 for titration, 12 of relatively stable dose, 4 of which at fixed doses; Study Period 1), risperidone given orally at a dose of 0.25-3.0 mg/day depending on body weight (equivalent to approximately 0.01-0.04 mg/kg/day is superior to placebo in preventing relapse of the symptoms of conduct disorder as assessed through a 12 week double-blind discontinuation trial (Study Period 2) of children and adolescents with conduct disorder and no developmental delay/mental retardation. This will be measured by comparing the mean change from the double-blind baseline to endpoint in the Nisonger Child Behaviour Rating Form Typical IQ version-ODD/CD disruptive behaviour composite total score (Aman et al., 2008) using all investigator ratings, based on all available information.
A Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children (P03579 AM3)
Oct 2012The purpose of this dose-escalation study is to evaluate the pharmacokinetics, safety, and tolerability of oral posaconazole in immunocompromised children with neutropenia or expected neutropenia.
Pharmacokinetics of Levosimendan in children with acute heart failure
Oct 2012To describe the pharmacokinetic profile of levosimendan in children
An international collaborative study to discontinue Imatinib/Glivec® in pediatric CML patients with sustained complete molecular response (STOPIMAPED)
Oct 2012To estimate the percentage of quantitative RT-PCR negative pediatric CML patients in which Imatinib discontinuation result in sustained complete molecular remission
An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus
Sep 2012The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with HCV on a telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.
A 6 Week, Randomized, Multicenter, Double-blind, Double-dummy Study to Evaluate the Dose Response of Valsartan on Blood Pressure Reduction in Children 1-5 Years Old With Hypertension, With or Without Chronic Kidney Disease, Followed by a 20 Week Openlabel Titration Phase
Sep 2012To evaluate if a dose dependent reduction in MSBP exists when comparing two doses of valsartan solution over a 6wk period in children 1-5 years old with hypertension with or without CKD.
An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin alfa in Paediatric Subjects From Birth to Less than 1 Year of Age With Anemia due to Chronic Kidney Disease
Sep 2012To evaluate the safety and tolerability of darbepoetin alfa following single 1.5 microgram/kg subcutaneous (SC) dose administration in paediatric subjects < 1 year of age with anaemia due to chronic kidney disease
An Open-label, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Darbepoetin alfa in Paediatric Subjects From Birth to Less than 1 Year of Age With Anemia due to Chronic Kidney Disease
Sep 2012To evaluate the safety and tolerability of darbepoetin alfa following single 1.5 microgram/kg subcutaneous (SC) dose administration in paediatric subjects < 1 year of age with anaemia due to chronic kidney disease
A phase IV study to evaluate decreased dose frequency in patients with active Systemic Juvenile Idiopathic Arthritis (SJIA) who experience laboratory abnormalities during treatment with tocilizumab
Aug 2012Efficacy: • To explore the efficacy of TCZ in reduced dosing frequency regimens (Q3W and Q4W, as appropriate) using Juvenile Arthritis Disease Activity Score (JADAS)-71, JIA flare, and fever Pharmacodynamic: • To describe the pharmacodynamics, using sIL-6R and C-reactive protein (CRP), and immunogenicity of TCZ in reduced dosing frequency regimens.
A phase III, open-label, multicentre study to evaluate the immunogenicity, safety and reactogenicity of a revaccination dose of the GlaxoSmithKline Biologicals' quadrivalent seasonal influenza candidate vaccine GSK2321138A, administered to children who previously participated in study 115345 (FLU D-QIV-004 PRI).
Aug 2012To assess the immune response in terms of Haemagglutination Inhibition (HI) antibody titre at Day 7 after one dose of FLU D-QIV vaccine (2012-2013 formulation) in vaccine-primed and vaccine-unprimed subjects, for all strains included in the vaccine.
A Phase 3 Study to Assess the Efficacy and Safety of Boceprevir in Combination with Peginterferon alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1
Aug 2012• To assess the efficacy of boceprevir used in combination with peginterferon alfa-2b (PEG2b) plus ribavirin (RBV) in non-cirrhotic, treatment naïve pediatric subjects with chronic hepatitis C (CHC) genotype 1. • To evaluate the safety and tolerability of BOC/PR in pediatric subjects. • To assess in pediatric subjects who are non-cirrhotic, treatment failures or who are cirrhotics the proportion of subjects who achieve SVR when they are retreated with BOC/PR. • To evaluate the safety and tolerability of BOC/PR in pediatric subjects who are non-cirrhotic, treatment failures or who are cirrhotics. • To confirm the durability of the virologic response in the subjects who were sustained responders at 24 weeks posttreatment in Part A or Part B. • To characterize the long-term safety of boceprevir, including growth assessment and sexual maturation, in subjects who received treatment in Part A or Part B.
Guided Self-Help for Parents of Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Aug 2012Cognitive-behavioral based guided self-help for parents of adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD) is investigated in a feasibility and effectiveness study. The treatment is offered under routine-care conditions of the health-care system in Germany. Practicability, treatment participation and effectiveness is documented and tested in a one-group pre-test/post-test design.
Exercise induced bronchoconstriction in children – a single dose of montelukast as alternative to regular daily doses.
Jul 2012To compare the effect of a single dose of montelukast and regular daily use of montelukast in children with exercise induced bronchoconstriction.
A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Relief of Heartburn, in Adolescent subjects Aged 12 to 17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease
Jul 2012To assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules (30 mg) in adolescent subjects aged 12 to 17 years, with symptomatic non-erosive GERD.
Protocol ALL-11:Treatment study protocol of the Dutch Childhood Oncology Group for children and adolescents (1-19 year) with newly diagnosed acute lymphoblastic leukemia
Jul 2012To treat children with ALL with the best available treatment as possible, based upon the risk factors of the patient at diagnosis.
Infliximab Top-down Study in Kids with Crohn’s disease
Jul 2012The primary objective of our study is to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD.
A Double-Blind, Placebo-Controlled, Randomized Withdrawal Study of the Safety and Efficacy of Memantine in Pediatric Patients with Autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Previously Treated with Memantine
Jun 2012To evaluate the safety, tolerability, and efficacy of memantine therapy compared with placebo in pediatric patients with autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) previously on stable memantine therapy utilizing a randomized withdrawal paradigm.
An Open-Label Study Of The Safety And Tolerability Of Memantine In Pediatric Patients With Autism, Asperger’s Disorder, Or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS)
Jun 2012The objective of this study is to evaluate the safety and tolerability of memantine in pediatric (6-12 years old) patients with autism, Asperger’s Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) and to identify responders for participation in the follow-up randomized withdrawal study
A long-term, open-label follow-up study of CP-690,550 for treatment of juvenile idiopathic arthritis (jia)
Jun 2012The objective of this study is to determine the long term safety and tolerability of CP 690,550 for treatment of the signs and symptoms of JIA.
Enhancement of Methylphenidate Treatment by Psychosocial Intervention and Support
Jun 2012The main purpose of this study is to evaluate the effectiveness of a parenting enhancement training (PET) for parents with children diagnosed with Attention Deficit-/Hyperactivity Disorder (ADHD) who are already medicated with methylphenidate.
A Phase 3, Randomized, Double-Blind, Multi-Center Study to Compare the Efficacy and Safety of Micafungin Versus Amphotericin B Deoxycholate for the Treatment of Neonatal Candidiasis
Jun 2012To evaluate the efficacy and safety of Micafungin in comparison to amphotericin B deoxycholate (CAB) in the treatment of proven neonatal candidiasis
An open-label multiple dose study to evaluate the pharmacokinetics, safety and tolerability of CP-690,550 in pediatric patients from 2 to less than 18 years of age with Juvenile Idiopathic Arthritis (JIA)
May 2012To characterize the PK and safety of CP 690,550 following multiple oral doses in pediatric patients (from 2 to less than 18 years) with active JIA.
Efficacy and safety of liraglutide in combination with metformin versus metformin monotherapy on glycaemic control in children and adolescents with type 2 diabetes
May 2012To confirm the superiority of liraglutide at the maximum tolerated dose (0.6 mg, 1.2 mg, 1.8 mg) in combination with metformin in controlling glycaemia versus metformin and liraglutide placebo in children and adolescent (ages 10–17 years) with type 2 diabetes.
Double blind placebo controlled randomized intervention study aiming at reducing dexamethasone related side effects in children with acute lymphoblastic leukemia (ALL).
May 2012To reduce dexamethasone induced cerebral side-effects on mood, behaviour, and cognition by intervention treatment with physiological doses of cortisol compared to placebo.
A prospective, multicenter, non-comparative, open label extension of the FUTURE 5 study to assess safety and tolerability of the pediatric formulation of bosentan in children with pulmonary arterial hypertension
May 2012To evaluate the long-term safety and tolerability of the pediatric formulation of bosentan at a dose of 2 mg/kg b.i.d. in children with pulmonary arterial hypertension (PAH).
A phase II, randomized, controlled, partially-blind study to demonstrate immunogenicity and assess safety of GlaxoSmithKline (GSK) Biologicals’ pneumococcal vaccines (2830929A and 2830930A) administered as a 3-dose primary vaccination course during the first 6 months of life and as a booster dose at 12-15 months of age.
Apr 2012• To demonstrate that 2830929A vaccine co-administered with DTPa-HBV-IPV/Hib as a three-dose primary vaccination course at approximately 2, 3, 4 months of age is non-inferior to Prevenar 13 or Synflorix in terms of percentage of subjects with antibody concentrations greater or equal to the seropositivity threshold AND in terms of ELISA Geometric Mean Concentrations (GMCs). • To demonstrate that 2830930A vaccine co-administered with DTPa-HBV-IPV/Hib at approximately 2, 3, 4 months of age is non-inferior to Prevenar 13 or Synflorix in terms of percentage of subjects with antibody concentrations greater or equal to the seropositivity threshold AND in terms of ELISA GMCs.
A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR Mutation
Apr 2012To evaluate the safety of long-term ivacaftor treatment in subjects with cystic fibrosis (CF)
Reactogenicity Study of Cervarix and Gardasil in UK Adolescent Girls
Mar 2012This is a phase IV study to evaluate the body's immune response of participants to the Cervarix and Gardasil vaccines against the Human Papilloma Virus (HPV) types associated with increased risk of cervical cancer.
Multicenter, Open-label Study to Assess the Pharmacokinetics, Pharmacodynamics, Efficacy, Safety, Tolerability, and Immunogenicity of a Single, Subcutaneous Dose of 100μg/kg XM22 in 21 Children with Ewing Family of Tumors or Rhabdomyosarcoma
Mar 2012The primary objective of the study is to assess the pharmacokinetics (PK) of a single subcutaneous (SC) injection of XM22, 100 μg/kg body weight (BW), in children with Ewing family of tumors or rhabdomyosarcoma.
A randomized, double-blind, placebo controlled trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of lixisenatide in paediatric (10 - 17 years old) and adult patients with type 2 diabetes
Mar 2012To investigate the effects of two single subcutaneous lixisenatide doses (5 and 10 µg) as compared to placebo in reducing postprandial glucose (PPG) in type 2 diabetic paediatric population (10-17 years old) and adults as controls
The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children with ADHD: A Randomised Placebo Controlled Trial
Mar 2012The primary objective of this study is to explore the relationship between MPH and academic activity and the mediating roles of ADHD behaviours, cognitive deficits and motivational deficits in this relationship. Therefore, the direct effects of MPH on ADHD behaviours, cognitive deficits and motivational deficits are taken into account. In particular, evidence on the effects of MPH on motivational deficits in ADHD is scarce. It is hypothesized that treatment with MPH results in increased academic activity as compared to placebo control. If MPH improves academic activity, comparisons with the control group will be made to see if academic activity in children with ADHD normalises when treated with MPH.
A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent Asthma
Feb 2012To demonstrate the dose-related efficacy by evaluating morning lung function at the end of the dosing interval (AM pre-dose percent predicted forced expiratory volume in one second [FEV1]) after 12 weeks of treatment, of three doses (50 mcg, 100 mcg, and 200 mcg) of mometasone furoate (MF) metered dose inhaler (MDI) twice a day (BID) compared with placebo in children 5 to 11 years of age, inclusive, with persistent asthma.
Tolerance and effect of an add-on therapy with an ivy leaves dry extract syrup on lung function in children with asthma.
Feb 2012To evaluate the effect of an additional therapy with Prospan on the lung function parameters MEF75-25 and FEV1 (relative change)
Effectiveness of homeopathic treatment (Agraphis nutans 5CH, Thuya occidentalis 5CH, Kalium muriaticum and Arsenicum iodatum 9CH 9CH) as adjuvant secretory otitis in children
Feb 2012Evaluate the effectiveness of homeopathy coadyuvancia of aerosol treatment (mucolytics, corticosteroids), secretory otitis in pediatric patients 2 months to 12 years, making an intervention group who receive homeopathy and the control group will receive placebo. It will compare the effectiveness measured by pneumatic otoscopy
Registration of Children With CML and Treatment With Imatinib (CML-paed II)
Jan 2012Protocol for Standardized Diagnostic Procedures, Registration, and Treatment Recommendations in Children and Adolescents With Philadelphia Chromosome-positive Chronic Myeloid Leukemia (CML)
Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways
Dec 2011The objective of this study is to evaluate safety of treatment with AZLI 75 mg 3 times daily (TID) for 3 courses of therapy (28 days on/28 days off) in female and male children less than 13 years of age with CF and chronic PA infection/colonization.
Intra-arterial Chemotherapy for Children With Retinoblastoma
Dec 2011Retinoblastoma is a cancer of the eye that occurs exclusively in children. The treatment for retinoblastoma may include surgery, chemotherapy, radiation and local treatments to the eye such as freezing (cryotherapy) and local radiation (brachytherapy). In some cases, a child with retinoblastoma will have active cancer in a single remaining eye with useful vision. In such cases, it is sometimes necessary to remove this eye. In such cases, the injection of chemotherapy directly into the artery that supplies the eye and the tumor may lead to regression of the tumor without the need to remove the eye. This form of treatment was pioneered by a group in New York (Abramson et al). In this study the investigators will assess the efficacy and safety of the technique in a group of children with retinoblastoma.
Quality of Life in Children Cured of Retinoblastoma
Dec 2011The aim of the study is to assess the quality of life of children who have been cured of retinoblastoma - a malignant eye tumor. The study is questionnaire-based, and uses standardized quality of life assessment tools.
Efficacy of RAD001/everolimus in Autism and NeuroPsychological deficits in children with TSC (RAPIT-trial)
Dec 2011The primary objective is to determine the effect of Everolimus on the cognition of children with TSC, measured by IQ.
HZA106853: A dose-ranging study of vilanterol (VI) inhalation powder in children aged 5-11 years with asthma on a background of inhaled corticosteroid therapy.
Nov 2011The primary objective is to evaluate the dose response, efficacy and safety of three doses of VI inhalation powder administered once daily in the evening in children aged 5-11 years with persistent uncontrolled asthma over a 4 week treatment period.
A multiple ascending dose study of Tadalafil to assess the pharmacokinetics and safety in a pediatric population with Pulmonary Arterial Hypertension
Nov 2011Main objective of the trial is to characterize the pharmacokinetics (PK) of tadalafil in a pediatric population with pulmonary arterial hypertension (PAH) to establish an appropriate dose range for further clinical research.
A Phase 3, Open-label, Multicentre, Protocol to Provide Access to Guanfacine Hydrochloride Extended Release for European Subjects with Attention-deficit/Hyperactivity Disorder (ADHD) who Participated in Study SPD503-315 or SPD503-316
Nov 2011The primary objective of this study is to evaluate the long term saftey of SPD503.
A 6-month safety and benefit study of inhaled fluticasone propionate/ salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 pediatric subjects 4-11 years old with persistent asthma
Nov 2011The primary objective is to evaluate whether the addition of a LABA to an ICS (FSC) therapy is non-inferior in terms of risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) compared with ICS alone (FP) in pediatric subjects (age 4-11 years) with persistent asthma.
International Study to Predict Optimized Treatment - in Attention-Deficit and Hyperactivity Disorder
Nov 2011The primary objectives of the iSPOT-A trial are to use Brain Resource's standardized 'Integrative Neuroscience' test batteries to 1) Identify objective markers of ADHD compared with healthy controls, using cognitive, brain and genetic markers
FLT-PET Imaging of Brain Tumors in Children
Oct 2011Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is important in the management of these tumors, but current imaging methods have limitations in providing the necessary information for optimal treatment of these patients. The goal of this study is to evaluate the potential utility of positron emission tomography (PET) with 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) in the medical management of brain tumors in children.
A Phase III, Multicenter, Double-Blind, Randomized, Placebo- and Metformin-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control
Oct 2011In pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control: (1) after 16 weeks, to assess the effect of treatment with sitagliptin compared with placebo on A1C (2) to assess the safety and tolerability of sitagliptin
Effects of Educational Intervention on Long-Term Outcomes of Hospitalized Children With Asthma (IHOP)
Sep 2011The investigators hypothesize that reinforced asthma education improves long-term outcomes in children with asthma.
An Efficacy Study of GlaxoSmithKline (GSK) Biologicals' Candidate Influenza Vaccine GSK2321138A in Children
Sep 2011The purpose of this study is to evaluate the efficacy, immunogenicity and safety of GSK Biologicals' influenza candidate vaccine GSK2321138A when compared to non-influenza vaccine comparators in children 6 to 35 months of age. Approximately half of the subjects will be recruited during the first study year and will be followed during approximately 6-8 months for efficacy and safety. The recruitment of an independent cohort during the second study year will be based on the results of the first year.
Long-term, interventional, open label extension study evaluating the safety of tocilizumab treatment in patients with polyarticular-course juvenile idiopathic arthritis from Germany who completed the global, multinational trial (WA19977)
Sep 2011To evaluate the long term safety of tocilizumab treatment in patients with pcJIA from Germany who entered this extension.
Study of Antibodies to Anti-TNF Agents in Juvenile Idiopathic Arthritis
Sep 2011The purpose of this study is to analyze the frequency of the formation of antibodies against three different anti-TNF biologic agents used for the therapy of juvenile idiopathic arthritis.
Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects with Chronic Hepatitis C Genotype 1 (Phase 1b)
Sep 2011To determine weight based doses of boceprevir for children 3 to 17 years of age.
Investigating Cognitive Behavioral Therapy in Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders
Sep 2011The purpose of this study is to determine if cognitive behavioral therapy is effective in treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.
An Open-Label Extension of the Dose Finding study (DSC/08/2357/36) in patients with polyarticular course Juvenile Idiopathic Arthritis (poly JIA)
Sep 2011The purpose of this extension study is to determine the safety of Givinostat in a long term treatment of patients who participated in DSC/08/2357/36 study with good results (clinical benefit al least pediACR30 response)
A phase IIIb parallel group, open label study of pegylated interferon alfa-2a monotherapy (PEG-IFN, Ro 25-8310) compared to untreated control in children with HBeAg positive chronic hepatitis B.
Aug 2011To compare HBeAg seroconversion (loss of HBeAg and presence of anti-HBe) between a group treated with PEG-IFN monotherapy and an untreated control group.
Amoxicillin Versus Benzyl Penicillin for Treatment of Children Hospitalised With Severe Pneumonia
Jul 2011This study seeks to determine whether clinical outcome following initial treatment of severe pneumonia with oral amoxicillin is as effective as the current standard benzyl penicillin. The study will also provide an estimate of the proportion of Kenyan children with severe pneumonia who fail treatment with a single antibiotic.
Prediction and Prevention of PEG-Asparaginase Associated Pancreatitis, Hepatotoxicity and Hyperlipidemia in Children With Acute Lymphoblastic Leukemia
Jul 2011The purpose of this study is to create a model enabling us to predict pancreatitis, hyperlipidemia and hepatotoxicity during treatment with PEG-Asparaginase in children with Acute Lymphoblastic Leukemia.
An efficacy, safety and pharmacokinetic study on the short-term and long-term use of METFORMIN in obese children and adolescents
Jul 2011The primary objective of the METFORMIN study is to determine the efficacy of metformin in combination with lifestyle-intervention in obese children and adolescents with insulin resistance versus placebo with lifestyle-intervention.
A Pharmacokinetic Study Of The Combined Use Of Recombinant Human GH And IGF-1 In Children With Inflammatory Bowel (Crohn’s) Disease
Jun 2011The objective of this study is to perform a short-term study to assess how well tolerated combined recombinant growth hormone therapy (rhGH) and insulin-like growth factor (rhIGF-1) therapy is compared to rhGh alone in children/adolescents with Crohn's disease. i.e. will it be acceptable to a child to give two injections in the morning? It is hoped that the results from this phase II study will provide the scientific and safety data to allow us to apply for regulatory permission to move on to a Phase III study of long term growth in children/adolescents whose growth is affected by their inflammatory bowel disease.
Social Cognitive Development in Young Children With Autism
Jun 2011Through the development of a novel treatment targeting core Autism Spectrum Disorder (ASD) social deficits and studying the efficacy of this intervention, the investigators hope to provide a means for children with ASD to more effectively and efficiently process social information and enable them to more successfully engage in social interactions. Children between the ages of 24 and 36 months and their families may join.
A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Complicated Urinary Tract Infections
May 2011The primary objective of this study is to establish the safety and tolerability profile of doripenem compared with that of cefepime in hospitalized children 3 months to <18 years of age with cUTI (complicated Urinary Tract Infection).
Effect of Adalimumab for the Treatment of Uveitis in Juvenile Idiopathic Arthritis (ADJUVITE)
May 2011The primary objective is to demonstrate a higher response rate at 2 months in the adalimumab arm versus the placebo arm.
Adolescents' Response to Hepatitis B Vaccine Booster Dose (REACH)
Apr 2011The aims of this study are to determine: the degree of immunity against hepatitis B, factors associated with immunity against hepatitis B, if the amount of antigen provided in a booster dose (used to measure the degree of immune memory) affects the body's response to the booster, and if the age at which the vaccination was initiated during infancy affects duration of protection against hepatitis B among adolescents 16-19 years of age born in the United States who were immunized against hepatitis B as infants. These data will be important to evaluate the potential need for a possible booster dose of hepatitis B vaccine among adolescents.
The role of anti-IgE (omalizumab) in the management of severe recalcitrant paediatric atopic eczema
Apr 2011To determine if anti-IgE can improve very severe eczema in children, who have not responded to the usual 1st and 2nd line treatments for eczema (assessed by the eczema severity score, SCORAD), as compared to a placebo.
Toolkit for School Behavior Modification in Children With Attention-Deficit/Hyperactivity Disorder (ADHD)
Apr 2011The purpose of this study is to examine the efficacy of the ADHD-Toolkit (a toolkit for school behaviour modification in primary school children with ADHD-behaviours) in terms of general improvement in ADHD symptoms, specific targeted school-related problem behaviours, other disruptive behaviour disorder symptoms, teacher attitudes towards ADHD, teacher-child relationship and child self-esteem.
Randomised Control Trial of the Clinical Effectiveness, Safety and Cost Effectiveness of Adalimumab in Combination with Methotrexate for the Treatment of Juvenile Idiopathic Arthritis Associated Uveitis.
Mar 2011To compare how effective the use of adalimumab, in combination with methotrexate versus methotrexate alone with regard to controlling disease activity in refractory uveitis associated with juvenile idiopathic arthritis.
Study of the Effects of Hypnosis Before Undergoing Surgery, on Anxiety in Children Aged 10 to 18 Years (HYPOPANX)
Mar 2011This study aims to find how hypnosis performed just before a painful surgery can change anxiety level, in children aged 10 to 18 years.
Operational Research Management for Children With Severe Pneumonia (OR-pneumonia)
Mar 2011The investigators Study Hypothesis is introduction of modified IMCI guideline for managing severe pneumonia in first level health facilities will result in 40% increase in the appropriate management (appropriate case management at the first level facility and referral compliance by the caregivers) of severe pneumonia cases in the intervention arm compared to the comparison arm.
A Multicentre, Open-label, Pharmacokinetic Study of Modigraf® (Tacrolimus granules) in de novo Paediatric Allograft Recipients.
Mar 2011The principal objective is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body. This is called pharmacokinetics (PK). The results will then help to decide how much Modigraf in future should be given to children and young people following transplantation.
Safety of Clofarabine With Multiagent Chemotherapy in Childhood Acute Lymphoblastic Leukemia (Vandevol)
Jan 2011The purpose of this study is to determine Maximum Tolerated Dosage (MTD), Dosage Limited Toxicities (DLT), and the Rate Phase 2 Dosage of clofarabine when used in combination with etoposide, asparaginase, mitoxantrone and dexamethasone and to assess the feasibility and safety of this combination regimen to treat children with high risk relapsed or refractory acute lymphoblastic leukemia (ALL).
A randomized, double-blind, placebo-controlled, multicenter study of the efficacy and safety of Ritalin® LA in adult patients with childhood-onset ADHD
Nov 2010Main objectives of the trial are; To confirm the clinically effective dose range of Ritalin LA in adults with childhood onset ADHD as measured by the change from Baseline to the end of a 9-week, fixed-dose treatment period in DSM-IV Attention-Deficit/Hyperactive Disorder Rating Scale (DSM-IV ADHD RS) total score. To evaluate improvement in functional impairment will be measured by the change from baseline in total score on the Sheehan Disability (SDS) is a self-rating scale designed to assess the functional impairment of patients with ADHD at the end of a 9-week fixed-dose treatment period. To evaluate the maintenance of effect of Ritalin LA in adults with childhood onset ADHD as measured by the percentage of Ritalin LA vs. placebo treatment failures at the end of a 6-month treatment withdrawal period. To evaluate the safety of Ritalin LA in adults with childhood onset ADHD as measured by the frequency of AEs, the results of laboratory tests, and the measurement of vital signs and ECGs.
Effects of methylphenidate on the development of the dopaminergic system in the brain
Nov 2010To report on the age-dependency of the effect(s) of MPH treatment on the outgrowth of the DA system using state-of-the-art Magnetic Resonance Imaging (MRI) techniques
A Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children With Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement Who Have Poor Response to Methotrexate (GO KIDS)
Oct 2010The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in patients who have active juvenile idiopathic arthritis (JIA) and at least 5 joints with active arthritis that have poor response to methotrexate.
A Phase 4, Open-label, Multicentre, 2-Year Safety Study of Lisdexamfetamine Dimesylate in Children and Adolescents Aged 6-17 Years with Attention-Deficit/Hyperactivity Disorder (ADHD)
Oct 2010To evaluate the long-term safety of SPD489 administered as a daily morning dose (30, 50, and 70mg) in the treatment of children and adolescents (6-17 years of age inclusive at the time of consent in this study or a previous SPD489 study (SPD489-317, SPD489-325, or SPD489-326) diagnosed with moderately to severely symptomatic ADHD.
Phase II Study for Safety and Efficacy Evaluation of Imatinib Mesylate in Children With Chronic Myeloid Leukemia (CML) Philadelphia Chromosome-positive (Ph+)
Oct 2010The purpose of this study is to evaluate the hematological, cytogenetic and molecular response to continuous-use of Imatinib in children with CML Ph+.
A Multi-Center, Open label, Repeated Dose Range Finding Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Efficacy of an Anti-IL-1β Monoclonal Antibody (ACZ885) Given Subcutaneously in Pediatric Subjects with Active Systemic Juvenile Idiopathic Arthritis (SJIA)
Oct 2010To evaluate the safety, tolerability and immunogenicity of sc administration of ACZ885 in pediatric subjects with active Systemic Juvenile Idiopathic Arthritis (SJIA).
A Phase 3, Randomised, Double-blind, Multicentre, Parallel-group, Placebo- and Active-reference, Dose-optimisation Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents aged 6-17 years with Attention-Deficit/Hyperactivity Disorder
Oct 2010The primary efficacy analysis will be performed on the change from baseline for the ADHD-RS-IV total score at Visit 15 using Last-Observation-Carried Forward (LOCF) methodology, for all subjects randomised and receiving study drug. The mean change from baseline will be compared between treatments using an Analysis of Covariance (ANCOVA) model. The primary treatment comparison is SPD503 versus placebo. The ANCOVA model will include treatment group (the effect of interest), the corresponding baseline score (the covariate), and the blocking factors age group (6-12 years or 13-17 years) and country. The null hypothesis states that there is no difference between SPD503 and placebo, with the 2-sided alternative of a non-zero difference between groups.
Remission Induction by Etanercept in Enthesitis related Arthritis JIA-Patients (juvenile undifferentiated Spondylarthropathy)
Sep 2010This study is intended to generate first evidence that treatment with etanercept is safe and effective in patients diagnosed with ERA-JIA who are able to aquire stable remission (inactive disease).
A Phase 3, Double-blind, Placebo-controlled, Multicentre, Randomised withdrawal, Long-term Maintenance of Efficacy and Safety Study of Extended-release Guanfacine Hydrochloride in Children and Adolescents Aged 6-17 With Attention deficit/Hyperactivity Disorder
Aug 2010The primary efficacy outcome for each subject is treatment failure during the double-blind randomised-withdrawal phase (Phase 2). The primary efficacy analysis will compare treatment failure rates between treatments (SPD503 and placebo) for all subjects who enter Phase 2 using a Cochran-Mantel-Haenszel (CMH) test stratified by age group and country. Subjects who discontinue for any reason during the randomised-withdrawal phase will be classed as treatment failures for the primary analysis. The null hypothesis states that there is no difference in treatment failure rate between SPD503 and placebo, with the 2-sided alternative of a non-zero difference between groups.
A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy
Aug 2010The primary objective of this study is to assess the clinical efficacy of SC administration of golimumab in pediatric subjects (ages 2 to less than 18 years) with JIA manifested by ≥ 5 joints with active arthritis despite methotrexate (MTX) therapy for ≥ 3 months.
Parents as the Agent of Change for Childhood Obesity (PAAC)
Aug 2010The overall intent of this study is to explore a promising mode for delivering treatment for childhood obesity via parent education only, and to evaluate the cost effectiveness compared to the current gold standard treatment of parent-and-child dual education.
Jointstrong Intervention for Juvenile Arthritis
Jul 2010The purpose of this study is to determine if using a CD-ROM program for juvenile arthritis can help children learn how to improve their symptoms on their own and reduce the frequency of symptoms.
A 15 week, randomized, double blind, parallel-group, placebo-controlled, flexible-dose, safety and efficacy study of pregabalin in adolescents (12-16 years old) with fibromyalgia
Jun 2010To evaluate the safety and efficacy of pregabalin (75-450 mg/day) compared with placebo in an adolescent fibromyalgia population.
Childhood Obesity Prevention Program for Hispanics
Jun 2010The purpose of this study is to evaluate the efficacy of a culturally-appropriate childhood obesity intervention with Hispanic families. The program aims at preventing childhood obesity by targeting parents to address nutrition, physical activity, and sedentary behaviors in their children.
Evaluation of an Intervention for Improving Community-based Pediatric Attention-Deficit Hyperactivity Disorder (ADHD) Care
Jun 2010Evaluation of an Intervention for Improving Community-based Pediatric ADHD Care
Effects Of Eslicarbazepine Acetate (Bia 2-093) On Cognitive Function In Children With Partial Onset Seizures: An Add-On, Double-Blind, Randomised, Placebo-Controlled, Parallel Group, Multicentre Clinical Trial
Jun 2010The primary study objective is to evaluate the effects of ESL on cognition in comparison with placebo as adjunctive therapy in children aged 6 to 16 years old with refractory partial-onset seizures (double blind 12 weeks)
A Single Centre, Open-Label, Randomised Multi-Dose Study to Assess Changes in the Brain Metabolism of Juvenile ADHD Patients After Thirteen Weeks of Daily Intake of 4 g Superba Krill Oil or 4 g omega-3 Enriched Fish Oil
May 2010To evaluate changes in the brain metabolism of juvenile ADHD patients after thirteen weeks of daily doses of 4 g Superba krill oil or 4 g omega-3 enriched fish oil
ADHD - Voice Analysis, Vocal Acoustic Biomarkers in Attention Deficit Hyperactivity Disorder
Apr 2010The purpose of this study is to detect specific vocal acoustic patterns in the voice of attention deficit hyperactivity disorder (ADHD) patients.
The effectiveness of Parent-Child Interaction Therapy versus methylphenidate in preschool children with ADHD and disruptive behavior problems with insufficient improvement through Parent Management Training.
Mar 2010The primary aim of our study will be to investigate the effectiveness of PCIT in comparison with methylphenidate in children with ADHD and disruptive behavior problems aged 2;6 till 6 years who have not responded sufficiently to previously offered PMT.
A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
Mar 2010To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated physiologically-based pharmacokinetic (PBPK) and population pharmacokinetics (pop PK) approaches.
A non-randomized, open-label study to characterize the pharmacokinetics of Glivec/Gleevec® (imatinib mesylate) in pediatric (age range 1 to less than 4 years) patients with chronic myeloid leukemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)
Mar 2010To characterize the pharmacokinetics of imatinib in pediatric patients age 1 to less than 4 years via appropriate integrated physiologically-based pharmacokinetic (PBPK) and population pharmacokinetics (pop PK) approaches. To assess the safety and tolerability of imatinib in pediatric patients age 1 to less than 4 during the study period.
A Worldwide, Randomized, Double Blind, Placebo-Controlled, Parallel Group Clinical Trial to Evaluate the Safety and Efficacy of Rizatriptan for the Acute Treatment of Migraine in Children and Adolescents
Feb 20101. To evaluate the efficacy of rizatriptan compared to placebo in the treatment of acute migraine as measured by pain freedom at 2 hours in pediatric migraineurs between 12 and 17 years of age who have not, historically, achieved satisfactory response to treatment with NSAIDS or APAP. 2. To evaluate the safety and tolerability of rizatriptan in pediatric migraineurs between 12 and 17 years of age who have not, historically, achieved a satisfactory response to treatment with NSAIDS or APAP.
A Worldwide, Open Label, Clinical Trial to Examine the Long Term Safety and Tolerability of Rizatriptan in Pediatric Migraineurs for the Treatment of Migraine With or Without Aura
Feb 2010To evaluate the safety and tolerability of rizatriptan in the long term treatment of acute migraine in pediatric patients age 12-17 years.
Genomic Analysis of Pediatric Bone Tumors
Jan 2010To determine whether gene expression analysis of primary tumor samples before and after chemotherapy are predictive of long-term survival in pediatric patients with bone sarcomas (Ewings sarcoma (ES) and Osteosarcoma(OS)).
Addressing Health Literacy and Numeracy to Prevent Childhood Obesity (GreenLight)
Dec 2009The aim of the study is to assess the efficacy of a low-literacy/numeracy-oriented intervention aimed at teaching pediatric resident physicians to promote healthy family lifestyles and prevent overweight among young children (age 0-2) and their families in under-resourced communities.
Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)
Dec 2009The primary objective of this study is to evaluate the safety of adalimumab in subjects 2 to < 4 years of age and subjects age 4 and above that weigh < 15 kg with moderately to severely active polyarticular JIA or polyarticular course JIA.
Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children 10-16 With Chronic Kidney Disease (CKD).
Nov 2009Safety and efficacy study using Paricalcitol capsules to decrease parathyroid hormone levels in children ages 10-16 with Chronic Kidney Disease.
Influence of a Dietary Supplement as Treatment of Migraine in Children and Adolescents
Nov 2009Migraine in children and adolescents can be associated with low serum levels of coenzyme q10, the key-enzyme of mitochondrial energy production.During migraine attacks inflammation is an important issue. Based on a double-blind placebo-controlled trial with coenzyme q10 in adults it is hypothesized that daily supplementation of coenzyme q10 as well as different antioxidative phytochemicals (from berries) and specific minerals and vitamins are able to reduce the "days with migraine" as primary parameter (open clinical trial).
Pilot Study Using a Dietary Intervention for Children With Irritable Bowel Syndrome
Oct 2009Malabsorption of certain foods (e.g. lactose) has been proposed as a cause of irritable bowel syndrome in adults and children. Recently, a diet that lowers intake of a combination of foods has been found to be effective in adults with IBS identified with fructose malabsorption. The purpose of this study is to determine whether a restricted fermentable substrate diet is effective in the treatment of irritable bowel syndrome in children.
An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations
Sep 2009• To assess the long-term safety, tolerability, and immunogenicity of canakinumab • To assess efficacy at an exploratory level by investigating disease control defined by maintenance of at least an adapted ACR pediatric 30 during the extension part
A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab.
Aug 2009Part I: Primary Objectives: 1. To assess the efficacy of tocilizumab versus placebo in combination with stable ongoing therapy, with regard to signs and symptoms in sJIA patients with persistent activity and an inadequate response to NSAIDs and systemic corticosteroids. 2. To evaluate the short term safety of tocilizumab versus placebo in combination with stable ongoing therapy, with regard to adverse events and laboratory assessments in patients with sJIA with persistent activity and an inadequate response to NSAIDs and corticosteroids. Part II: Primary Objectives: 1. To evaluate the safety of tocilizumab in chronic administration; 2. To assess the effect of tocilizumab to enable the reduction or elimination of corticosteroids Part III: Primary Objectives 1. To assess the long-term safety of 8 mg/kg tocilizumab in children > 30 kg and 12 mg/kg tocilizumab in children < 30 kg with regard to adverse events and laboratory result abnormalities;
A 2-Part Open-label Study to Assess the Clinical Benefit and Long-term Safety of Etanercept in Children and Adolescents With Extended Oligoarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, or Psoriatic Arthritis
Aug 2009Part 1: To assess the clinical benefit of etanercept in subjects with extended oligoarticular JIA, ERA, or PsA. Part 2: To assess the long-term safety of etnaercept in subjects with extended oligoarticular JIA, ERA, or PsA.
A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation
Jul 2009Part A: To evaluate the pharmacokinetics of a single dose of orally administered VX 770 treatment in subjects 6 to 11 years of age with cystic fibrosis (CF) who have the G551D cystic fibrosis transmembrane conductance regulator (CFTR) mutation on at least 1 allele. Part B: To evaluate the efficacy of VX 770 after 24 weeks of treatment in subjects 6 to 11 years of age with CF who have the G551D CFTR mutation on at least 1 allele.
A Phase 3b, Double-blind, Randomised, Active-controlled, Parallel-group Study to Compare the Time to Response of Lisdexamfetamine Dimesylate to Atomoxetine Hydrochloride in Children and Adolescents aged 6-17 years with Attention Deficit/Hyperactivity Disorder (ADHD) Who Have Had an Inadequate Response to Methylphenidate Therapy.
Jul 2009The primary objective of this study is to compare the time to response of lisdexamfetamine dimesylate (SPD489) with that of atomoxetine hydrochloride (STRATTERA) in subjects who are judged by the Investigator to have had an inadequate response to methylphenidate (MPH) treatment where inadequate response includes, but is not limited to, the presence of some residual symptoms, inadequate duration of action and/or variability of symptom control, and/or Investigator feels that the subject may derive benefit from an alternative treatment to MPH therapy. The primary efficacy measure is time to response; where individual subject response is assessed using the Clinical Global Impressions – Global Improvement (CGI-I) Scale.
A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis
Jul 2009To compare the proportion of patients on tocilizumab versus placebo who develop a JIA ACR30 flare (compared to week 16) by week 40.
Management of children following acute pyelonefritis or recurrent urinary tract infection episodes and prevention of renal scarring: a prospective randomised controlled clinical trial.
Jul 2009To identify the best management to reduce renal damage in patients with APN and UTI and to improve their quality of life.
The Role of Anti-Reflux Surgery for Gastroesophageal Reflux Disease in Premature Infants With Bronchopulmonary Dysplasia (GERD-BPD)
Jun 2009The purpose of this study is to evaluate the efficacy of fundoplication in premature infants with GERD and BPD.
Effect of domperidone and omeprazole in gastro-oesophageal reflux disease in infants between 0 and 2 years.
Jun 2009To measure the effect of domperidone and omeprazole on reflux-time, duration, and symptoms of GERD
Why methylphenidate is not successful in cocaine-dependent ADHD patients: a SPECT study comparing DAT before and after methylphenidate treatment in ADHD patients with and without cocaine dependence
May 2009To determine why methylphenidate is not successful in cocaine-dependent ADHD patients, using SPECT to comparing DAT before and after methylphenidate treatment in ADHD patients with and without cocaine dependence
Comparison of the efficacy of intrarticular corticosteroid therapy administered alone or in combination with methotrexate in children with juvenile idiopatic arthritis: a phase II, randomized acticely controlled, multicenter trial
Mar 2009To investigate wheter the concomitant administration of methotrexate leads to a significant prolongation of the efficacy of intrarticular corticosteroid therapy in children with oligoarticular-onset juvenile idiopatic arthritis
Pediatric Asthma Alert Intervention for Minority Children With Asthma (PAAL)
Mar 2009Young inner-city children with asthma have the highest emergency department (ED) visit rates. Relying on the emergency department for asthma care can be a dangerous sign of poorly controlled asthma. This research will focus on whether having a specialized asthma nurse join the family at a child's doctor visit after an ED visit for asthma to make sure the child and parent keep the follow-up appointment and have the nurse remind the child's doctor to prescribe preventive asthma medicines and an asthma action plan for home (PAAL intervention) will result in young children with asthma having fewer days with wheezing and cough. The investigators hypothesize that: Significantly more children receiving the PAAL intervention will attend greater than 2 non-urgent visits and greater than 6 refills for the child's anti-inflammatory medications over 12 months when compared to children in the control or standard asthma education group. Also children in the PAAL intervention group will experience less morbidity and caregivers will experience increased quality of life compared to children in the control of standard asthma education group.
Parents, Pediatricians, and Asthma Telephone Coaches Partner to Improve Control of Asthma in Children (The PARTNER Study)
Mar 2009Parents of children with asthma must work with their child's pediatrician to ensure that their child's asthma is managed well. Asthma coaches are one way to facilitate and support the relationship between parents and pediatricians. This study will evaluate whether access to a 12-month telephone asthma coaching program for parents is an effective way to improve asthma outcomes in children.
CML-SCT -IBFM Study Allogeneic stem cell transplantation for children and Adolescents with CML: Conditioning regimen, donor selection, supportive care and diagnostic procedures.
Feb 2009To evaluate whether transplant related mortality following allogeneic stem cell transplantation from unrelated donors for CML can be reduced by using a reduced intensity conditioning regimen. To prospectively evaluate the overall survival, the event free survival and the current leukemia free survival in patients undergoing allogeneic stem cell transplantation for CML using a standardised post-transplant monitoring and early intervention
Sleep and Obesity in Teenagers
Feb 2009This study aims to investigate 1.whether sleep extension results in improvements of endocrine and metabolic markers of obesity and diabetes in obese teenagers, 2.the relationship between habitual sleep quality and duration and markers of obesity and diabetes in lean and obese teenagers
A multi-centre, double-blind, placebo-controlled, randomised group-comparative study to evaluate the efficacy and safety of Altoderm, a topically applied sodium cromoglicate lotion, in the treatment of atopic dermatitis in children.
Jan 2009To evaluate the efficacy and safety of topically applied Altoderm in the treatment of atopic dermatitis in children.
Effect of montelukast on levels of metalloproteinase-9 (MMP-9), MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1), procollagen peptide type 1 C-terminal (PICP) and TGF-beta1 on induced sputum of children suffering from intermittent asthma.
Dec 2008To evaluate if 4-weeks treatment with montelukast in children affected by intermittent asthma can significantly reduce levels of TIMP-1 on induced sputum.
ALL2008 Protocol for Childhood Acute Lymphoblastic Leukemia (ALL) - 6MP Consolidation Therapy (ALL2008con)
Dec 2008Nordic Society of Paediatric Haematology and Oncology (NOPHO) Treatment Protocol for Children (1.0 - 17.9 Years of Age) and Young Adults With Acute Lymphoblastic Leukemia. Efficacy of Individualised 6MP Dosing During Consolidation Therapy.
Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia
Nov 2008The primary objective of this study is to evaluate the pharmacokinetics (PK) of posaconazole (POS) administered orally at three dosage levels to immunocompromised children aged 3 months to <18 years with neutropenia or expected neutropenia.
Phase 1B Study of the Safety, Tolerance, and Pharmacokinetics of Oral Posaconazole in Immunocompromised Children With Neutropenia
Nov 2008The primary objective of this study is to evaluate the pharmacokinetics (PK) of posaconazole (POS) administered orally at three dosage levels to immunocompromised children aged 3 months to <18 years with neutropenia or expected neutropenia.
Impact of the V0034CR 01B emollient on atopic dermatitis symptoms in children. A randomised, placebo-controlled, parallel-groups, double-blind study
Aug 2008To evaluate, in children presenting with atopic dermatitis, the impact of a daily treatment by the emollient V0034CR 01B on the disease symptoms: evolution of the POEM (Patient-Oriented Eczema Measure) score.
A trial of position control therapy (PCT) for treatment of infantile gastro-oesophageal reflux
Jul 2008Assess the effect of position control therapy on symptoms due to gastro-oesophageal reflux in infatns 0-6 months of age.
Neurocognitive testing in children with ADHD
Jun 2008Main objectives of the trial are; 1. to measure the effects of methylphenidate using the Neurocart test battery, to establish if these effects can be differentiated from placebo and to determine circadian variation in effect, 2. to describe the drug concentrations of methylphenidate in saliva, 3. to describe the PK/PD relationship using the obtained saliva samples, 4. to describe cardiovascular effects of methylphenidate (blood pressure and heart rate); 5. to evaluate clinical treatment effect during the trial, 6. to evaluate how children have experienced trial participation.
A Phase III, Open-Label, Extension, Multicentre, Safety Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 with Attention-Deficit/Hyperactivity Disorder (ADHD)
May 2008The primary objective of this study is to evaluate the long-term safety of LDX administered as a daily morning dose (30, 50, and 70mg/day) in the treatment of children and adolescents (6 -17 years of age inclusive at the time of consent for the antecedent study, SPD489-325) diagnosed with moderately symptomatic ADHD. The evaluation of safety will be based on the occurrence of treatment-emergent adverse events (TEAEs), specific evaluation of blood pressure and pulse, electrocardiogram (ECG) results, clinical laboratory test results, and physical examination findings.
Multicenter randomized clinical trial in Patients with Juvenile Idiopathic Athritis: Safety and efficacy of vaccination with live attenuated Measles, Mumps, Rubella vaccine
Feb 2008To study the safety of measles, mumps, rubella (MMR) booster vaccination in Juvenile Idiopathic Arthritis (JIA) patients by measuring JIA disease activity.
Phase III Study of Multimodality Therapy Comprising Induction Chemotherapy, High-Dose Consolidation Chemotherapy, Autologous Stem Cell Transplantation, and/or Radiotherapy in Children With Extraocular Retinoblastoma
Feb 2008- To estimate the proportion of children with extraocular retinoblastoma who achieve long-term event-free survival after treatment with aggressive multimodality therapy compared to historical controls. - To estimate the response rate to the induction phase of the regimen. - To evaluate the toxicities associated with this regimen.
Adolescent Type 1 Diabetes Cardio-Renal Intervention Trial
Jan 2008To determine whether intervention with Angiotensin Converting Enzyme Inhibitors (ACEI), Statins, or a combination of both, when compared with placebo, will reduce urinary albumin excretion, decline in renal function and the risk for diabetic nephropathy (DN) and cardiovascular disease (CVD)
Mitochondrial Function in Pediatric Obesity
Dec 2007This study evaluates a novel, non invasive, safe method for predicting insulin resistance and diabetes in children using a magnetic resonance imaging (MRI) based technique to measure mitochondrial function. We propose to investigate mitochondrial function and glucose metabolism in obese and non-obese children in early, mid and late puberty.
Influence of methylphenidate on sleep and circadian rhythm in children with Attention-Deficit/Hyperactivity Disorder (ADHD)
Nov 2007Determine the influence of methylphenidate treatment on sleep-wake rhythm and endogenous melatonin rhythm in children with ADHD.
A double-blind, randomised, placebo-controlled, multi-centre study to assess the efficacy and safety of adjunctive zonisamide in paediatric partial onset seizures
Sep 2007To assess the efficacy of zonisamide in paediatric epilepsy subjects with partial onset seizures treated with one or two other AEDs.
A double-blind, randomized, placebo-controlled study of early oseltamivir treatment of influenza in children 1-3 years of age
Sep 2007The primary objective is to evaluate the efficacy of early oseltamivir treatment of influenza in children 1-3 years of age
A multicenter, randomized, double-blind clinical study to examine the efficacy and safety of Zarzenda® in comparison to Elidel® in the management of mild to moderate atopic dermatitis in children and adolescents.
Sep 2007The primary objective of the study is to show therapeutic efficacy of Zarzenda® cream versus Elidel® 1% cream in children and adolescents with mild to moderate atopic dermatitis.
A Prospective Study to Determine the Adverse Drug Reactions Profile of Anticonvulsants in Children
Jul 2007To prospectively determine the nature and rate of adverse drug reactions, or side effects, in children on anticonvulsants.
A Randomized, Double-Blind, Active Comparator Study to Evaluate the Antihypertensive Efficacy and Safety of Losartan/HCTZ Combination as Compared to Losartan Monotherapy in Pediatric Patients With Essential Hypertension
May 2007To evaluate the antihypertensive efficacy (as assessed by change in mean trough SiSBP) after 4 weeks of treatment with losartan/HCTZ combination therapy in comparison with losartan monotherapy in pediatric patients (defined as children aged 6-17 years who have the ability to swallow tablets) with essential hypertension (defined as patients ≥ the 95th percentile for SBP or DBP for gender/age/height) who are not adequately controlled following a 6-week single-blind losartan treatment (filter) period.
A Randomized, Controlled, Open-Label Study of the Long-Term Impact on Functioning using Atomoxetine Hydrochloride Compared to Other Early Standard Care in the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Treatment-Naïve Children and Adolescents. (ADHD-LIFE Study)
Feb 2007The primary objective is to test the hypothesis that atomoxetine given at individually titrated doses for 6 months is superior to other early standard therapy in improving quality of life as measured by the mean change in the achievement domain of the Child Health and Illness Profile – Child Edition, Parent Report Form (CHIP-CE PRF), in pharmacologically naïve children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease
Feb 2007The primary objectives of this study are the following: 1. To test if the proportion of subjects achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa QW for treatment of anemia in pediatric subjects with chronic kidney disease receiving and not receiving dialysis, and 2. To test if the proportion of subjects achieving a hemoglobin value greater than or equal to 10.0 g/dL at any time point after the first dose during the study is greater than 0.8 when administered de novo darbepoetin alfa Q2W for treatment of anemia in pediatric subjects with chronic kidney disease receiving and not receiving dialysis.
Allogenic stem cell transplantation in children and adolescents with acute lymphoblastic leukaemia
Jan 2007To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). To evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.
An open-label study of two single oral doses of galantamine, examining the pharmacokinetics, safety, and tolerability in children with Down syndrome
Dec 2006To determine the pharmacokinetic characteristics of glantamine after 2 single oral doses in children with Down syndrome.
A Study to Assess the Anamnestic Immune Response 4 to 6 Years After a Primary Vaccination Series With HBVAXPRO™
Jun 2006To assess the quality of the priming of HBVAXPRO™ by demonstrating acceptability of the anamnestic response after a booster dose (of either modified process hepatitis B vaccine or ENGERIX B™) in healthy children 4 to 6 years of age. To determine the ability of subjects to mount an anamnestic immune response to either HBVAXPRO™ or ENGERIX-B™. To assess the safety and tolerability of a booster dose of a modified process hepatitis B vaccine in healthy children 4 to 6 years of age
Omega-3 Fatty Acids Supplementation for Adolescent Boys with Attention Deficit Hyperactivity Disorder : a double-blind, randomized controlled trial
Apr 2006ADHD symptoms are often carried through to the adolescent period and long-term intervention is often needed. Patients and their parents often choose alternative treatments for ADHD. Omega-3 fatty acids supplementation is one popular alternative treatment, and relatively safe, but the effectiveness has not been assessed enough . This study aims to evaluate whether EFA supplementation improves ADHD symptoms in ADHD male adolescents.
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