Clinical trials: Pediatric Safety and Effectiveness
Obstruction of Pelviureteric Junction
The Efficacy and Safety of Local Anesthetic Infusion With Ropivacaine
The investigators propose a prospective blinded randomized control trial (RCT) to assess the efficacy and safety of a simple method of continuous infusion of a local anesthetic, ropivacaine, via a surgical wound to control pain…
- Trial name
- NCT00930046
- Testing
- Ropivacaine wound catheter, Saline wound catheter
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Boston Children's Hospital
Progressive Keratoconus
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus
This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that limit their capacity to comply with the…
- Trial name
- CXL (NCT00925327)
- Testing
- Corneal collagen cross-linking with riboflavin/UVA light
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Peschke Meditrade, GmbH
Venous Thromboembolism
Apixaban for the Acute Treatment of Venous Thromboembolism in Children
To assess the safety and descriptive efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.
- Trial name
- NCT02464969
- Testing
- Apixaban, Standard of Care
- Where
- 128 sites in United States, Australia and 11 more
- Volunteers
- 229 people
- Sponsor
- Bristol-Myers Squibb
Epilepsy
A Clinical Study to Investigate the Efficacy and Safety of Lacosamide as an Add on Therapy in Children With Epilepsy With Partial-onset Seizures
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of lacosamide (LCM) in pediatric subjects.
- Trial name
- NCT01964560
- Testing
- Lacosamide
- Where
- 141 sites in United States, Argentina and 33 more
- Volunteers
- 540 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Gaucher Disease
A Safety and Efficacy Study of Two Dose Levels of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
This is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase alfa in untreated subjects (2 to <18 years old) with Gaucher disease randomly assigned to treatment with one of two doses, 30 or 60…
- Trial name
- NCT01132690
- Testing
- Taliglucerase alfa
- Where
- 3 sites in Israel, Paraguay and 1 more
- Volunteers
- 11 people
- Sponsor
- Pfizer
CHARGE Syndrome
A Strategic Approach to Safe and Effective Cochlear Implantation in Patients With CHARGE Syndrome
This retrospective observational study aims to evaluate cochlear anatomy, surgical challenges, and strategic approaches for safe cochlear implantation in pediatric patients with CHARGE syndrome.
- Trial name
- NCT07320482
- Testing
- No intervention (observational study)
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Seoul National University Bundang Hospital
COVID-19
EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease
The purpose of this clinical trial is to learn about the safety, pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it), and efficacy (how well a study…
- Trial name
- NCT05261139
- Testing
- nirmatrelvir, ritonavir
- Where
- 73 sites in United States, Bulgaria and 5 more
- Volunteers
- 160 people
- Sponsor
- Pfizer
Psoriasis
An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric participants aged greater than or equal to (>=) 6 through less than (<) 12 years with moderate to severe chronic plaque psoriasis
- Trial name
- CADMUS Jr (NCT02698475)
- Testing
- Ustekinumab 0.75 mg/kg, Ustekinumab 45 mg, Ustekinumab 90 mg
- Where
- 31 sites in United States, Belgium and 7 more
- Volunteers
- 44 people
- Sponsor
- Janssen Research & Development, LLC
Short Bowel Syndrome
Characterization of the Long-term Safety, Efficacy, and Pharmacodynamics Revestive® in the Management of Short Bowel Syndrome Pediatric Patients
The purpose of this study is to evaluate if the treatment could maximize intestinal absorption, minimize the inconvenience of diarrhea, and avoid, reduce or eliminate the need for parenteral support (PS) to achieve normal growth…
- Trial name
- REVE (NCT03562130)
- Testing
- Teduglutide
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Depression, Bipolar I Disorder
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States.
- Trial name
- 3112 Ped BPD (NCT04777357)
- Testing
- Cariprazine
- Where
- 81 sites in United States, Puerto Rico and 1 more
- Volunteers
- 380 people
- Sponsor
- AbbVie
Arthritis, Juvenile
A Study to Evaluate the Pharmacokinetics, Efficacy and Safety of Intravenous Golimumab in Pediatric Participants With Active Polyarticular Course Juvenile Idiopathic Arthritis Despite Methotrexate Therapy
The purpose of this study is to evaluate the pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) of golimumab administered intravenously (IV) to pediatric participants with…
- Trial name
- GO-VIVA (NCT02277444)
- Testing
- Golimumab, Methotrexate
- Where
- 38 sites in United States, Argentina and 7 more
- Volunteers
- 130 people
- Sponsor
- Janssen Research & Development, LLC
X-linked Hypophosphatemia (XLH)
Study to Assess the Safety, Pharmacokinetics and Efficacy of KRN23 in Pediatric Chinese Patients With XLH
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of KRN23 in pediatric Chinese patients with XLH
- Trial name
- NCT04842032
- Testing
- KRN23
- Where
- 5 sites in China
- Volunteers
- 28 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Familial Hypercholesterolemia - Homozygous
Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children With Homozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 2 to <12 years) with homozygous familial hypercholesterolemia (HoFH) and elevated low density lipoprotein…
- Trial name
- ORION-19 (NCT06597006)
- Testing
- Inclisiran
- Where
- 19 sites in United States, Austria and 9 more
- Volunteers
- 9 people
- Sponsor
- Novartis Pharmaceuticals
Psoriasis Vulgaris, Psoriatic Arthritis
Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP
This was a multicenter, centrally registered observational study without a control group. This observational study was a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during…
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis, Pustular Psoriasis
- Trial name
- NCT05215561
- Testing
- Cosentyx
- Where
- 21 sites in Japan
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic…
- Trial name
- NCT00981214
- Testing
- EUR-1008 (APT-1008)
- Where
- 14 sites in United States
- Volunteers
- 19 people
- Sponsor
- Forest Laboratories
Central Nervous System Diseases
Safety and Efficacy of MultiHance in Pediatric Patients
The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.
- Trial name
- NCT00323310
- Testing
- gadobenate dimeglumine
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Bracco Diagnostics, Inc
Attention Deficit Disorder With Hyperactivity
Phase IIa Exploratory Clinical Trial, to Examine the Safety and Efficacy of tPCS on Paediatric ADHD Participants
Children with ADHD display a certain brainwave profile which might be different to that of a child who does not have ADHD. Treatment with tPCS (transcranial pulsed current stimulation) has shown that this brainwave profile could…
- Trial name
- NCT02323633
- Testing
- Braingear Brainbuds Pulsed Current stimulation device
- Volunteers
- 48 people
- Sponsor
- Braingear Technologies GmbH
Moderate to Severe Plaque Psoriasis
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to <18 years of age with moderate to severe…
- Trial name
- BE TOGETHER (NCT06425549)
- Testing
- bimekizumab, ustekinumab
- Where
- 42 sites in United States, Belgium and 8 more
- Volunteers
- 176 people
- Sponsor
- UCB Biopharma SRL
Atopic Dermatitis (Eczema)
Pharmacokinetics (PK), Safety, Efficacy and Maximal Use PK of ARQ-151 in Adolescents/Children With Mild/Moderate Eczema
This is a research study where all subjects will receive study medication to understand how the body processes the study medication, and to determine the PK, safety and efficacy of ARQ-151 cream 0.15% or 0.05% in adolescent and…
- Trial name
- NCT04156191
- Testing
- ARQ-151 cream 0.15%, ARQ-151 cream 0.05%
- Where
- 10 sites in United States
- Volunteers
- 101 people
- Sponsor
- Arcutis Biotherapeutics, Inc.
Pediatric Hereditary Kidney Diseases
The Efficacy and Safety of Dapagliflozin in the Treatment of Hereditary Kidney Disease With Proteinuria in Children
This study is a multicenter, randomized controlled crossover trial aimed to evaluate the efficacy and safety of dapagliflozin in the treatment of hereditary kidney disease with proteinuria in children
- Trial name
- NCT06890143
- Testing
- Dapagliflozin+Standard Treatment for 12 weeks,washout period for 4 weeks，then Standard Treatment alone for12 weeks, Standard Treatment alone for 12 weeks ,washout period for 4 weeks ,then Dapagliflozin+Standard Treatment for 12 weeks
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Children's Hospital of Fudan University
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