Clinical trials: Pediatric Disease
Perennial Allergic Rhinitis
A Long-Term Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
The objective of this study is to evaluate the long-term safety and efficacy of TAU-284 (Bepotastine besilate) in pediatric patients with perennial allergic rhinitis for 12 weeks administration.
- Trial name
- NCT01900054
- Testing
- Bepotastine besilate
- Where
- Japan
- Volunteers
- 58 people
- Sponsor
- Tanabe Pharma Corporation
GM1 Gangliosidosis, GM2 Gangliosidosis
Natural History Study for Pediatric Patients With Early Onset of Either GM1 Gangliosidosis, GM2 Gangliosidoses, or Gaucher Disease Type 2
This study is being conducted to better understand the natural course of GM1 gangliosidosis, GM2 gangliosidoses and Gaucher disease Type 2 (GD2).
- Conditions
- GM1 Gangliosidosis, GM2 Gangliosidosis, Gaucher Disease, Type 2, Tay-Sachs Disease
- Trial name
- RETRIEVE (NCT04470713)
- Where
- 17 sites in United States, Belgium and 8 more
- Volunteers
- 226 people
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction
Researchers are looking for a better way to treat children who have heart failure with left ventricular systolic dysfunction (LVSD).
- Trial name
- FIORE (NCT07188805)
- Testing
- Finerenone (Kerendia, BAY94-8862)
- Where
- 133 sites in United States, Argentina and 21 more
- Volunteers
- 111 people
- Sponsor
- Bayer
Schizophrenia
A Short Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia
The objective of this study is to investigate the efficacy and safety of three different doses of aripiprazole (2 mg/day, 6-12 mg/day, 24-30 mg/day) orally administered over a period of 6 weeks in pediatric patients (aged 13-17…
- Trial name
- NCT01942161
- Testing
- Aripiprazole Low (2 mg/day), Aripiprazole Mid (6 - 12 mg/day), Aripiprazole High (24 - 30 mg/day)
- Where
- 8 sites in Japan
- Volunteers
- 106 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Growth Disorders
Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Czech Republic
This is Multicentre, Observational Study to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of adherence of subject…
- Trial name
- ECOS CZ (NCT01400997)
- Testing
- easypod™
- Where
- Czechia
- Volunteers
- 206 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Wheezing, Reactive Airway Disease
A Study of the Pharmacokinetics, Safety and Tolerability of Single Doses of VR647 Inhalation Suspension Administered Using the VR647 Inhalation System in Children With Wheezing, Reactive Airway Disease or Mild Asthma
The primary objective of this study is to evaluate budesonide levels in the blood following inhalation of single doses of VR647 Inhalation Suspension in children with wheezing, reactive airway disease or mild asthma using a…
- Conditions
- Wheezing, Reactive Airway Disease, Mild Asthma
- Trial name
- NCT03421730
- Testing
- VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System, 1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- Vectura Limited
Urinary Bladder, Neurogenic
Open-label Long-term Extension Study of Fesoterodine in Japanese Subjects With Neurogenic Detrusor Overactivity.
The purpose of this study is to investigate the safety and tolerability of fesoterodine following once daily long-term treatment in Japanese pediatric neurogenic detrusor overactivity (NDO) subjects.
- Trial name
- NCT02501928
- Testing
- Fesoterodine PR 4 mg, Fesoterodine PR 8 mg, Fesoterodine BIC 2 mg
- Where
- 7 sites in Japan
- Volunteers
- 12 people
- Sponsor
- Pfizer
Meningococcal Infections
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in Europe
Primary objective: This study aimed to demonstrate the non-inferiority of the antibody response against meningococcal serogroups A, C, Y, and W following the administration of a 3-dose series of MenACYW conjugate vaccine compared…
- Trial name
- NCT03547271
- Testing
- MenACYW conjugate vaccine, Meningococcal group A, C, W-135, and Y conjugate vaccine, DTaP-IPV-HB-Hib vaccine
- Where
- 33 sites in Czechia, Finland and 5 more
- Volunteers
- 1,660 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Generalized Myasthenia Gravis
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
The purpose of the study is to assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized Myasthenia Gravis (gMG) aged ≥2 at the time of the…
- Trial name
- NCT06540144
- Testing
- rozanolixizumab
- Where
- 9 sites in Italy, Japan and 2 more
- Volunteers
- 13 people
- Sponsor
- UCB Biopharma SRL
Asthma
Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects That Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population
The objective of this study is to compare asthma-related exacerbations (emergency department (ED) or inpatient (IP) visit) and related cost in pediatric patients aged 4-11 years that received either fluticasone propionate 44 mcg…
- Trial name
- NCT01328964
- Testing
- Fluticasone propionate, Budesonide, Montelukast
- Volunteers
- 9,906 people
- Sponsor
- GlaxoSmithKline
Hypothyroidism
Thyroid Function of Pediatric Subjects Following Isovue® Administration
This is a Phase IV prospective, multicenter, observational study to estimate the proportion of subjects 0 to 3 years of age who develop abnormal thyroid function after exposure to intravascular administration of ISOVUE for the…
- Trial name
- NCT03779906
- Testing
- Isovue
- Where
- 4 sites in United States
- Volunteers
- 17 people
- Sponsor
- Bracco Diagnostics, Inc
Anemia, Renal Insufficiency, Chronic
Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.
Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable…
- Trial name
- NCT03552393
- Testing
- Mircera
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 40 people
- Sponsor
- Hoffmann-La Roche
Cystic Fibrosis
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)
This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the pharmacokinetic (PK), safety, and tolerability of multiple doses of tezacaftor (TEZ) in combination with ivacaftor (IVA) in subjects 6…
- Trial name
- NCT02953314
- Testing
- TEZ, TEZ/IVA, IVA
- Where
- 33 sites in United States, Canada
- Volunteers
- 83 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Lennox Gastaut Syndrome
Carisbamate in Adult & Pediatric Subjects With Lennox-Gastaut Syndrome
This is an open-label, multi-center study of carisbamate in adult and pediatric subjects with LGS, with single- and multiple-dose PK assessments from Days 1 through 73.
- Trial name
- NCT03731715
- Testing
- Carisbamate
- Where
- 7 sites in United States
- Volunteers
- 18 people
- Sponsor
- SK Life Science, Inc.
Systemic Lupus Erythematosus
Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy
This is a multi-center study to evaluate the safety, pharmacokinetics, and efficacy of belimumab intravenous (IV) in pediatric patients 5 to 17 years of age with active systemic lupus erythematosus
- Trial name
- PLUTO (NCT01649765)
- Testing
- Belimumab 10 mg/kg
- Where
- 32 sites in United States, Argentina and 8 more
- Volunteers
- 93 people
- Sponsor
- GlaxoSmithKline
Seasonal Allergic Rhinitis
Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)
This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of Japanese pediatric participants with seasonal allergic rhinitis (SAR).
- Trial name
- NCT01857063
- Testing
- Montelukast
- Volunteers
- 220 people
- Sponsor
- Organon and Co
Scoliosis
Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis
To compare the accuracy and feasibility, curvature correction and clinical outcomes of pedicle screw instrumentation with versus without robotic guidance, in pediatric and adolescent scoliosis patients
- Trial name
- PEDSCOLI (NCT02084264)
- Where
- 4 sites in United States
- Volunteers
- 272 people
- Sponsor
- Mazor Robotics
Colitis, Ulcerative
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction…
- Trial name
- QUASAR Jr (NCT06260163)
- Testing
- Guselkumab Subcutaneous, Guselkumab Intravenous
- Where
- 61 sites in United States, Australia and 11 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Chalazion, Hordeolum
Pediatric Zylet Safety and Efficacy Study
A multicenter study to evaluate the safety and efficacy of Zylet compared to vehicle in children aged 0-6 for the management of lid inflammation (chalazion/hordeolum)
- Trial name
- NCT00420628
- Testing
- loteprednol etabonate/tobramycin opthalmic suspension, vehicle
- Where
- United States
- Volunteers
- 108 people
- Sponsor
- Bausch & Lomb Incorporated
Osteoporosis
The Effect of Norgestimate/Ethinyl Estradiol on Bone Density in Pediatric Subjects With Anorexia Nervosa
The purpose of this study is to evaluate the effect of norgestimate/ethinyl estradiol on lumbar spine (L1-L4) and total hip bone mineral density (BMD) in pediatric subjects with anorexia nervosa.
- Trial name
- NCT00320567
- Testing
- norgestimate/ethinyl estradiol
- Volunteers
- 123 people
- Sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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