Clinical trials: Pediatric Disease
Onychomycosis
Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population
Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated topically with P-3058 nail solution according to the…
- Trial name
- NCT02547701
- Testing
- P-3058
- Where
- 5 sites in Belgium, Germany and 3 more
- Volunteers
- 20 people
- Sponsor
- Polichem S.A.
Asthma
Pharmacokinetic and Pharmacodynamic Profiles of Albuterol Spiromax® and ProAir® Hydrofluoroalkane (HFA) in Pediatric Patients With Asthma
The primary objective of this study is to compare the pharmacokinetic (PK) profiles of Albuterol Spiromax® and ProAir HFA after administration of a single inhaled dose of 180 mcg albuterol base from each product.
- Trial name
- NCT01844401
- Testing
- Albuterol Spiromax®, ProAir® HFA
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Psoriasis
Etanercept (Enbrel®) in Psoriasis - Pediatrics
This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with Psoriasis.
- Trial name
- NCT00078819
- Testing
- Etanercept
- Volunteers
- 211 people
- Sponsor
- Amgen
Short Bowel Syndrome
Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition
Teduglutide is approved for treatment of adults with short bowel syndrome (SBS). The purpose of this study is to evaluate the safety and efficacy of teduglutide in children up to the age of 17 with SBS who are dependent on…
- Trial name
- NCT02682381
- Testing
- Teduglutide 0.05mg/kg, Teduglutide 0.025 mg/kg, Standard of Care
- Where
- 27 sites in United States, Belgium and 5 more
- Volunteers
- 59 people
- Sponsor
- Shire
Spinal Muscular Atrophy Type I
Study of Safety, Tolerability and Efficacy of GB221 in Infants With Spinal Muscular Atrophy Type 1
GB221 is a gene therapy that delivers a working SMN1 gene to the motor neurons of people with spinal muscular atrophy (SMA) Type 1. This study will evaluate the safety, tolerability and efficacy of GB221 in two groups: 1.
- Trial name
- NCT07070999
- Testing
- GB221
- Where
- Brazil
- Volunteers
- 22 people
- Sponsor
- Gemma Biotherapeutics
Ulcerative Colitis
Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.
- Trial name
- PACE (NCT02093663)
- Testing
- MMX Mesalamine/Mesalazine (Low Dose), MMX Mesalamine/Mesalazine (High Dose)
- Where
- 33 sites in United States, Canada and 5 more
- Volunteers
- 107 people
- Sponsor
- Shire
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.
HIV/AIDS
REMUNE HIV/AIDS Vaccine Phase II Pediatric Safety & Efficacy Clinical Study
The primary objective is to compare \& evaluate between the treatment groups the changes in decline/reduction of HIV viral load \& increase changes in WBC white blood cell counts in the adult Remune dose vs the low dose Remune…
- Trial name
- NCT02291809
- Testing
- REMUNE
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Immune Response BioPharma, Inc.
Otitis Media, Infections, Respiratory Tract
Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India
Augmentin (ES)-600 is a high-dose amoxicillin/clavulanic acid 14:1 formulation that allows administration at 90/6.4 milligrams (mg)/kilograms (kg)/day in two divided doses.
- Conditions
- Otitis Media, Infections, Respiratory Tract, Respiratory Tract Infections
- Trial name
- NCT04600752
- Testing
- Augmentin (ES)-600
- Where
- 13 sites in India
- Volunteers
- 310 people
- Sponsor
- GlaxoSmithKline
Schizophrenia
A Long-term, Extended Treatment Study of Aripiprazole in Pediatric Patients With Schizophrenia
The objective of this study is to investigate the safety and efficacy of aripiprazole (initial dose 2 mg/day, maintenance dose 6-24 mg/day, maximum dose 30 mg/day) orally administered over a period of 52 weeks in subjects who…
- Trial name
- NCT01942148
- Testing
- Aripiprazole
- Where
- 8 sites in Japan
- Volunteers
- 68 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Infections, Human Immunodeficiency Virus and Herpesviridae
Relative Bioavailability Study of a Pediatric Granule Formulation of Dolutegravir
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor currently in Phase 3 clinical trials for the treatment of human immunodeficiency virus (HIV) infection.
- Trial name
- NCT01382238
- Testing
- Dolutegravir 50 mg tablet, Dolutegravir 50 mg oral granules
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Growth Hormone Deficiency
A Single Dose Study to Evaluate the PK-PD Response and Safety of PHA-794428 in Children With Growth Hormone Deficiency
This will be the first clinical study of the development of PHA-794428 in a pediatric population. Since differences in PK and/or PD response may occur between adult and pediatric subjects, it is deemed appropriate to first…
- Trial name
- NCT00314938
- Testing
- PHA-794428
- Where
- 7 sites in Belgium, France and 3 more
- Volunteers
- 32 people
- Sponsor
- Pfizer
Muscular Atrophy, Spinal
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered in Pediatric Patients With Spinal Muscular Atrophy Who Experienced a Plateau or Decline in Function After Gene Therapy
This is an open-label, single-arm, multicenter clinical study to evaluate the effectiveness and safety of risdiplam administered in pediatric participants with SMA and 2 SMN2 copies who previously received onasemnogene…
- Trial name
- HINALEA 2 (NCT05861999)
- Testing
- Risdiplam
- Where
- 17 sites in United States, Germany and 4 more
- Volunteers
- 19 people
- Sponsor
- Hoffmann-La Roche
Hay Fever, Perennial Allergic Rhinitis
Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)
The purpose of this study is to evaluate the safety and tolerability of ciclesonide nasal spray for long term use in relieving symptoms in perennial allergic rhinitis.
- Trial name
- NCT00261287
- Testing
- Ciclesonide
- Where
- 3 sites in United States
- Volunteers
- 102 people
- Sponsor
- AstraZeneca
Encephalitis, Tick-Borne
Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years
blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children
- Trial name
- NCT00452621
- Testing
- blood draw
- Where
- 8 sites in Germany
- Volunteers
- 235 people, healthy volunteers welcome
- Sponsor
- Novartis
Influenza
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
- Trial name
- NCT00972816
- Testing
- MF59-eH1N1
- Where
- 35 sites in United States, Mexico
- Volunteers
- 1,357 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
HCV Infection
Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)
The purpose of this study is to assess the pharmacokinetics (PK), safety, and efficacy of oral MK-5172 (a fixed dose combination [FDC] tablet containing elbasvir [EBR] 50 mg and grazoprevir [GZR] 100 mg) and EBR/GZR (varying…
- Trial name
- NCT03379506
- Testing
- EBR/GZR FDC Tablet, Grazoprevir Oral Granules, Elbasvir Oral Granules
- Where
- 15 sites in United States, Germany and 2 more
- Volunteers
- 57 people
- Sponsor
- Merck Sharp & Dohme LLC
Sickle Cell Disease
A Phase 2 Open-label Study to Evaluate the Activity of Etavopivat on Transcranial Doppler Velocities in Pediatric Patients With Sickle Cell Disease Who Are at Increased Risk for Primary Stroke
The study will test a new medicine, etavopivat, for sickle cell disease and see if it is safe and help-ful for participants with sickle cell disease who are at an increased risk of stroke.
- Trial name
- HIBISCUS 3 (NCT05953584)
- Testing
- Etavopivat, Hydroxyurea
- Where
- 9 sites in India, Nigeria and 1 more
- Volunteers
- 27 people
- Sponsor
- Forma Therapeutics, Inc.
Pediatric ALL
Investigation of Remimazolam in Children Undergoing Sedation for Medical Procedures
To assess the efficacy of intravenous remimazolam in inducing and maintaining suitable sedation levels for paediatric patients undergoing diagnostic and/or therapeutic procedures
- Trial name
- NCT04851717
- Testing
- Remimazolam
- Where
- 8 sites in United States, Denmark
- Volunteers
- 100 people
- Sponsor
- Acacia Pharma Ltd
Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors
Pharmacokinetics, Safety, and Efficacy of Brigatinib Monotherapy in Pediatric and Young Adult Participants With ALK+ Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors or Other Solid Tumors
The purpose of this study is to estimate the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) regimen and characterize the pharmacokinetics (PK) of brigatinib monotherapy (film-coated tablets and age-appropriate…
- Conditions
- Anaplastic Lymphoma Kinase Positive (ALK +) Anaplastic Large Cell Lymphoma, Inflammatory Myofibroblastic Tumors, Solid Tumors
- Trial name
- NCT04260009
- Testing
- Brigatinib, Brigatinib AAF
- Sponsor
- Takeda
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