Clinical trials: Pediatric Patient
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
Respiratory Syncytial Virus Infection
Surveillance of Synagis in Korean Pediatric Patients
Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study.
- Trial name
- NCT01537198
- Volunteers
- 618 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Respiratory Insufficiency, Respiratory Failure
Cross-over Comparison of the V60 System to Other Bi-Level Noninvasive Ventilators
The purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.
- Trial name
- NCT00817804
- Testing
- Use of the V60 Mask Ventilator
- Where
- Canada
- Volunteers
- 3 people
- Sponsor
- Respironics, California, Inc.
Medullary Thyroid Cancer, Infantile Myofibromatosis
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.
- Conditions
- Medullary Thyroid Cancer, Infantile Myofibromatosis, Infantile Fibrosarcoma, Papillary Thyroid Cancer
- Trial name
- LIBRETTO-121 (NCT03899792)
- Testing
- Selpercatinib
- Where
- 26 sites in United States, Australia and 9 more
- Volunteers
- 36 people
- Sponsor
- Eli Lilly and Company
Chronic Pain
Open-Label Safety and PK Study of ER Hydromorphone Tablets in Opioid-Tolerant Pediatric Chronic Pain Patients
This pediatric study is designed to provide safety information, dosing guidelines, and a pharmacokinetic (PK) evaluation of once-daily hydromorphone hydrochloride (HCl) extended-release (ER) tablets in children with chronic…
- Trial name
- NCT02321319
- Testing
- Hydromorphone HCl ER Tablets
- Where
- 3 sites in United States
- Volunteers
- 5 people
- Sponsor
- Mallinckrodt
Psoriasis
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin.
- Trial name
- OptIMMize-1 (NCT04435600)
- Testing
- Risankizumab, Ustekinumab
- Where
- 53 sites in United States, Canada and 5 more
- Volunteers
- 139 people
- Sponsor
- AbbVie
Asthma
Pharmacokinetics and PharmacoDynamics of GW685698 in Paedeatric Asthmatic Patients
This study will investigate the effect of dosing with flutucasone furoate in asthmatic subjects aged 5-11 years of age. A randomized, two-way crossover, with placebo control, over a 14 day treatment period, it will investigate…
- Trial name
- NCT01332292
- Testing
- Fluticasone furoate
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- GlaxoSmithKline
Hypertension
Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses.
- Trial name
- NCT01150357
- Testing
- Aliskiren (6.25/12.5/25 mg), Aliskiren (37.5/75/150 mg), Aliskiren (150/300/600 mg)
- Where
- 48 sites in United States, Belgium and 7 more
- Volunteers
- 267 people
- Sponsor
- Novartis Pharmaceuticals
Acute Heart Failure
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure
The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients with acute heart failure (AHF)
- Trial name
- RELAX-PEDS-PK (NCT02151383)
- Testing
- Serelaxin
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Hereditary Tyrosinemia, Type I
Taste and Palatability of Orfadin Suspension
The purpose of this study is to verify that pediatric patients, especially those who are not old enough to swallow capsules, accept the taste and palatability of a new suspension.
- Trial name
- NCT01734889
- Testing
- Nitisinone
- Where
- 7 sites in France, Germany and 1 more
- Volunteers
- 18 people
- Sponsor
- Swedish Orphan Biovitrum
Iron Overload
Safety Study of Crushed Deferasirox Film Coated Tablets in Pediatric Patients With Transfusional Hemosiderosis
This study employed a prospective, single-arm, global multi-center interventional open-label, non-randomized design to identify and assess safety profile of the crushed deferasirox FCT when administered up to 24 weeks in…
- Trial name
- MIMAS (NCT03372083)
- Testing
- Deferasirox
- Where
- 10 sites in Egypt, Italy and 5 more
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
End Stage Renal Disease
Triferic Pediatric Pharmacokinetic Protocol
The main purpose is to determine the pharmacokinetics (PK) of Triferic iron administered intravenously in pediatric patients with chronic kidney disease on chronic hemodialysis (CKD-5HD).
- Trial name
- NCT02595437
- Testing
- Triferic
- Where
- 9 sites in United States
- Volunteers
- 22 people
- Sponsor
- Rockwell Medical Technologies, Inc.
Asthma
Assessment of the Safety and Efficacy of Dupilumab in Children With Asthma (Liberty Asthma Excursion)
Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study.
- Trial name
- NCT03560466
- Testing
- Dupilumab (SAR231893/REGN668), Asthma controller therapies (incl. prednisone/prednisolone), Asthma reliever therapies
- Where
- 81 sites in United States, Argentina and 16 more
- Volunteers
- 378 people
- Sponsor
- Sanofi
Pain, Fever
Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.
- Trial name
- NCT02583399
- Testing
- Ibuprofen
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Cumberland Pharmaceuticals
Asthma
Study to Compare the Pharmacokinetics of Mometasone Furoate Alone and in Combination With Indacaterol in Patients ≥ 6 to < 12 Years Old With Asthma
This clinical study was designed to assess the pharmacokinetics, safety and tolerability of single inhaled doses of mometasone furoate (MF) when administered alone via MF Twisthaler® (TH) or as an indacaterol acetate/MF fixed…
- Trial name
- NCT04589663
- Testing
- Mometasone furoate, QMF149, Standard of Care (Soc)
- Where
- 3 sites in Hungary, South Africa
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Atopic Dermatitis
Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in…
- Trial name
- NCT03911401
- Testing
- 0.3% OPA-15406, 1% OPA-15406
- Where
- Japan
- Volunteers
- 251 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Perennial Allergic Rhinitis
A Confirmatory Study of TAU-284 in Pediatric Patients With Perennial Allergic Rhinitis
The objectives of this study are: to confirm the superiority of TAU-284 over placebo after two weeks of administration to pediatric patients with perennial allergic rhinitis, and to investigate the dose response, safety, and…
- Trial name
- NCT01425632
- Testing
- TAU-284
- Where
- 5 sites in Japan
- Volunteers
- 490 people
- Sponsor
- Tanabe Pharma Corporation
Transfusional Iron Overload, β-thalassemia Major
A 4-year Extension Study to Core 1-year Study of Iron Chelation Therapy With Deferasirox in β-thalassemia Major Pediatric Patients With Transfusional Iron Overload.
In this 4-year extension study the safety, efficacy and and pharmacokinetics of deferasirox in regularly transfused pediatric patients with β-thalassemia major was assessed.
- Conditions
- Transfusional Iron Overload, β-thalassemia Major, Pediatric Rare Anemia
- Trial name
- NCT00390858
- Testing
- Deferasirox
- Where
- 4 sites in France, Italy
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C, Chronic
5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
Study P02538 Part 2 is a 5-year long term follow-up (LTFU) study in pediatric participants who were treated with at least one dose of peginterferon alfa-2b (PEG-IFN) and ribavirin (RBV) and who completed the follow-up in the…
- Trial name
- NCT00761735
- Testing
- Peginterferon alfa-2b, Ribavirin
- Volunteers
- 94 people
- Sponsor
- Merck Sharp & Dohme LLC
Constipation
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.
- Trial name
- NCT00452335
- Testing
- Lubiprostone
- Where
- 19 sites in United States
- Volunteers
- 127 people
- Sponsor
- Sucampo Pharma Americas, LLC