Clinical trials: Pediatric Population
Healthy Volunteers
A Study to Evaluate the Relative Bioavailability of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects
This is a Phase 1, open-label, randomized, parallel-group, single-dose study. Approximately 56 participants will be enrolled and randomized into 1 of the 2 treatment groups, with 28 participants in each treatment group as…
- Trial name
- NCT04528290
- Testing
- Ozanimod
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Celgene
Partial Onset Seizures
A Safety, Efficacy, and Tolerability Trial of Pregabalin as Add-On Treatment in Pediatric Subjects <4 Years of Age With Partial Onset Seizures.
This study is designed to evaluate the effectiveness of 2 doses of pregabalin to reduce seizure frequency as an add on therapy in pediatric subjects 1 month to <4 years of age with refractory partial onset seizures.
- Trial name
- NCT02072824
- Testing
- Pregabalin Dose Level 1, Pregabalin Dose Level 2
- Where
- 72 sites in United States, Belarus and 21 more
- Volunteers
- 175 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Influenza
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in a Healthy Pediatric Population in the USA
The purpose of this study is to evaluate the immunogenicity and safety profile of CSL425 (CSL's 2009 H1N1 influenza vaccine) in a healthy pediatric population.
- Trial name
- NCT00958243
- Testing
- CSL's 2009 H1N1 Influenza Vaccine (CSL425)
- Where
- 13 sites in United States
- Volunteers
- 473 people, healthy volunteers welcome
- Sponsor
- Seqirus
Major Depressive Disorder
Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder (VLZ-MD-22)
The purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone compared with placebo in pediatric outpatients (7-17 years of age) with major depressive disorder.
- Trial name
- VLZ-MD-22 (NCT02372799)
- Testing
- Vilazodone, Fluoxetine
- Where
- 60 sites in United States, Canada
- Volunteers
- 473 people
- Sponsor
- Forest Laboratories
Influenza, Human
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2015/2016 Quadrivalent Influenza Vaccine…
- Trial name
- NCT02545543
- Testing
- Seqirus QIV, Comparator QIV
- Where
- 32 sites in United States
- Volunteers
- 2,278 people, healthy volunteers welcome
- Sponsor
- Seqirus
Cough
Dextromethorphan Pediatric Acute Cough Study
This is a placebo-controlled, double-blind, randomized, parallel group pilot study in approximately 150 subjects to evaluate the efficacy of dextromethorphan hydrobromide (DXM) on acute cough in a pediatric population.
- Trial name
- CHPA DXM (NCT02651116)
- Testing
- Dextromethorphan Hydrobromide, Cough recording device
- Where
- 18 sites in United States
- Volunteers
- 131 people
- Sponsor
- Pfizer
Asthma
Montelukast Back to School Asthma Study (0476-340)
This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.
- Trial name
- NCT00461032
- Testing
- montelukast
- Volunteers
- 1,162 people
- Sponsor
- Organon and Co
Niemann-Pick Disease, Type C1
Phase 3 Study to Evaluate Intravenous Trappsol(R) Cyclo(TM) in Pediatric and Adult Patients With Niemann-Pick Disease Type C1
A prospective, randomized, double-blind, placebo controlled, multi-center therapeutic study for patients age 3 and older with confirmed diagnosis of Niemann Pick disease type C1 (NPC1).
- Trial name
- TransportNPC (NCT04860960)
- Testing
- Hydroxypropyl-beta-cyclodextrin
- Where
- 35 sites in United States, Argentina and 11 more
- Volunteers
- 94 people
- Sponsor
- Cyclo Therapeutics, Inc.
Gastroesophageal Reflux Disease (GERD)
A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients
The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the treatment of acid-related disorders in pediatric patients, focusing specifically on the manifestation of GERD (symptomatic and erosive…
- Trial name
- NCT00787891
- Testing
- rabeprazole
- Volunteers
- 127 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Asthma
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma
This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160 mcg/day) administered via breath-actuated inhaler…
- Trial name
- NCT02040766
- Testing
- Beclomethasone dipropionate BAI, albuterol/salbutamol 90 mcg, Beclomethasone dipropionate MDI
- Where
- 102 sites in United States, Croatia and 3 more
- Volunteers
- 628 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Primary Disease or Condition Being Studied: Angelman Syndrome (AS)
A Study of OV101 in Individuals With Angelman Syndrome (AS)
The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.
- Trial name
- NEPTUNE (NCT04106557)
- Testing
- Gaboxadol
- Where
- 14 sites in United States, Australia and 3 more
- Volunteers
- 104 people
- Sponsor
- Ovid Therapeutics Inc.
Multiple Sclerosis, Relapsing-Remitting
A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis
This study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric…
- Trial name
- NCT03958877
- Testing
- BIIB017 (peginterferon beta-1a), Interferon beta type 1a
- Where
- 65 sites in United States, Argentina and 20 more
- Volunteers
- 152 people
- Sponsor
- Biogen
Chemotherapy Induced Nausea and Vomiting
Pharmacokinetics and Safety of Sancuso and IV Granisetron in Pediatrics Aged 6 to 12 Years
The purpose of this study is to determine the dosing strategy for adolescents aged 6 to 12 years.
- Trial name
- NCT01596413
- Testing
- Sancuso, IV granisetron
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Functional Constipation (FC)
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
The goal of this clinical trial is to learn if plecanatide can treat functional constipation in children and adolescents aged 6 to less than 18 years.
- Trial name
- Trulance (NCT07723924)
- Testing
- plecanatide
- Where
- 29 sites in United States
- Volunteers
- 180 people
- Sponsor
- Bausch Health Americas, Inc.
Anesthesia
CARE--Childhood Awareness and Recall Evaluation
The purpose of this study is to describe the incidence of recall or awareness under anesthesia in children aged 5-15 by collecting anesthetic and post-operative follow-up data relating to intra-operative recall during general…
- Trial name
- NCT00308984
- Where
- 3 sites in United States
- Volunteers
- 1,784 people
- Sponsor
- Medtronic - MITG
Attention Deficit Hyperactivity Disorder
Safety and Efficacy of MTS Versus Concerta in Pediatric Patients (Aged 6-12 Years) With ADHD
Study designed to evaluate the safety and efficacy of MTS compared to placebo with reference to CONCERTA® in pediatric subjects diagnosed with ADHD.
- Trial name
- NCT00444574
- Testing
- Methylphenidate Transdermal System, Concerta
- Volunteers
- 282 people
- Sponsor
- Noven Therapeutics
Diabete Mellitus
FreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations
This study is a non-randomized, single-arm, multi-center study that is designed to evaluate the safety and effectiveness of the FreeStyle Libre Flash Glucose Monitoring Systems in pediatric populations.
- Trial name
- NCT03369899
- Testing
- FreeStyle Libre Flash Glucose Monitoring System
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Abbott Diabetes Care
Restless Legs Syndrome
Dose Escalating Study of Rotigotine in Pediatric Subjects With Restless Legs Syndrome
This was a multicenter, open-label, dose-escalation, Phase 2A study with multiple administrations of the rotigotine transdermal system.
- Trial name
- NCT01495793
- Testing
- Rotigotine
- Where
- 12 sites in United States
- Volunteers
- 42 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Pediatric Hypertension
Atacand Dose Range Finding Study in Pediatric Subjects 6 to <17 Years of Age
Study 261A is a dose-ranging and safety study of candesartan cilexetil. It is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel-group study with a 4 week treatment period in hypertensive…
- Trial name
- NCT00244634
- Testing
- candsartan cilexetil
- Where
- 44 sites in United States, Belgium and 2 more
- Volunteers
- 238 people
- Sponsor
- AstraZeneca
Atopic Dermatitis
A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD
This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of…
- Trial name
- NCT03539601
- Testing
- Crisaborole ointment, 2%, Hydrocortisone butyrate cream, 0.1%, Pimecrolimus cream, 1%
- Where
- 32 sites in United States, Germany and 5 more
- Volunteers
- 237 people
- Sponsor
- Pfizer