Clinical trials: Pediatric Population
Chemotherapy Induced Nausea and Vomiting
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years
The purpose of this study is to determine the dosing strategy for adolescents aged 13 to 17 years.
- Trial name
- NCT01596400
- Testing
- granisetron transdermal system, Granisetron IV
- Where
- 12 sites in United States
- Volunteers
- 19 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Sickle Cell Disease
Study to Evaluate the Effect of Ticagrelor Versus Placebo in Reducing Vaso-Occlusive Crises Rate in Pediatric Patients With Sickle Cell Disease.
The purpose of this study is to compare the effect of ticagrelor vs placebo for the reduction of Vaso-Occlusive crises in paediatric patients with Sickle Cell Disease
- Trial name
- HESTIA5 (NCT04293172)
- Testing
- Brilinta
- Sponsor
- AstraZeneca
Hematologic Malignancy
Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population
Single-site non-significant risk, open-label clinical investigation designed to validate the usability, adherence, and preliminary diagnostic performance of a novel technology to detect neutropenia.
- Trial name
- PC004 (NCT04889937)
- Testing
- PointCheck
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Leuko Labs, Inc.
Fanconi Anemia Complementation Group A
A Clinical Trial to Evaluate the Safety of RP-L102 in Pediatric Subjects With Fanconi Anemia Subtype A
The objective of this study is to assess the therapeutic safety and preliminary efficacy of a hematopoietic cell-based gene therapy consisting of autologous CD34+ enriched cells transduced with a lentiviral vector carrying the…
- Trial name
- NCT03814408
- Testing
- RP-L102
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Rocket Pharmaceuticals Inc.
Asthma
Fall Epidemic Viral Pediatric Study
Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma exacerbation(s).
- Trial name
- NCT01192178
- Testing
- FLOVENT™ DISKUS™ 100 mcg BID, ADVAIR™ DISKUS™ 100/50 mcg BID
- Where
- 38 sites in United States
- Volunteers
- 339 people
- Sponsor
- GlaxoSmithKline
Autism
An Open Label Study of CM-AT for the Treatment of Children With Autism
This is a Phase III, open label extension study evaluating the continued safety and efficacy of CM-AT in pediatric patients with autism with all levels of fecal chymotrypsin.
- Trial name
- NCT02649959
- Testing
- CM-AT
- Where
- 31 sites in United States
- Volunteers
- 405 people
- Sponsor
- Curemark
Malnutrition
Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age
Demonstrate the safety and efficacy of Kabiven compared to standard parenteral nutrition (PN) administered via central vein in pediatric patients (2 to 16 years of age) requiring PN to meet nutritional needs.
- Trial name
- NCT03481894
- Testing
- Kabiven®, Compounded standard parenteral nutrition
- Where
- 2 sites in United States
- Sponsor
- Fresenius Kabi
Malaria, Falciparum
Efficacy and Safety of the Pediatric Formulation of Artemether- Lumefantrine in Children With Uncomplicated P. Falciparum Malaria.
This study will evaluate the safety and efficacy of artemether-lumefantrine against uncomplicated malaria caused P. falciparum in children of 5-35 kg bodyweight.
- Trial name
- NCT00386763
- Testing
- Artemether-lumefantrine
- Where
- 5 sites in Benin, Kenya and 3 more
- Volunteers
- 890 people
- Sponsor
- Novartis
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
Hernia, Inguinal, Flat Foot
The Efficacy and Safety of Chloroprocaine 1% and 2% in Pediatric Population
Randomized, multi-center, double-blind, two-armed, parallel active groups, prospective trial to evaluate the efficacy and safety of local anesthetic Chloroprocaine at two different concentrations ( at 1% and 2%) in a pediatric…
- Trial name
- NCT03918798
- Testing
- Chloroprocaine 1% Injectable Solution, Chloroprocaine 2% Injectable Solution
- Where
- 9 sites in Italy, Spain
- Volunteers
- 164 people
- Sponsor
- Sintetica SA
Proteinuria
An Extension Study Designed to Assess Effects of Losartan on Proteinuria in Pediatric Populations (MK-0954-326 AM1,EXT1(AM2))
The purpose of this study is to evaluate the effects of losartan on proteinuria in pediatric patients.
- Trial name
- NCT00568178
- Testing
- Losartan Potassium, Comparator: amlodipine besylate
- Volunteers
- 306 people
- Sponsor
- Organon and Co
Epilepsy, Epilepsies, Partial
Pediatric Epilepsy Study
This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
- Trial name
- NCT00050934
- Testing
- oxcarbazepine
- Where
- 30 sites in United States, Brazil and 2 more
- Volunteers
- 132 people
- Sponsor
- Novartis Pharmaceuticals
Pediatric Migraine
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
- Trial name
- NCT04649242
- Testing
- Rimegepant/BHV3000
- Where
- 246 sites in United States, Canada and 7 more
- Volunteers
- 2,100 people
- Sponsor
- Pfizer
Hearing Loss, Sensorineural
Expanded Indications in the MED-EL Pediatric Cochlear Implant Population
The purpose of this investigation is to demonstrate the safety and effectiveness of MED-EL cochlear implants in children 7 months to 5 years, 11 months of age who fall outside the current FDA-approved candidacy criteria and, yet…
- Trial name
- NCT03900897
- Testing
- MED-EL SYNCHRONY PIN Cochlear Implant, Cochlear Implant
- Where
- 8 sites in United States
- Volunteers
- 247 people
- Sponsor
- Med-El Corporation
Molybdenum Cofactor Deficiency, Type A
Safety & Efficacy Study of ORGN001 (Formerly ALXN1101) in Pediatric Patients With MoCD Type A Currently Treated With rcPMP
This study will include a screening period, a 6-month treatment period, followed by long-term extension period expected to last approximately 72 months.
- Trial name
- NCT02047461
- Testing
- ORGN001 (formerly ALXN1101)
- Where
- 6 sites in United States, Australia and 3 more
- Volunteers
- 8 people
- Sponsor
- Origin Biosciences
Schizophrenia, Mania
Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
- Trial name
- NCT00102479
- Testing
- Aripiprazole
- Volunteers
- 21 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Relapsing-Remitting Multiple Sclerosis, Relapsing Forms of Multiple Sclerosis
Placebo-Controlled Study of the Efficacy and Safety of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS)
The primary objective of the study is to assess the efficacy of oral BG00012 as compared with placebo in pediatric subjects with relapsing-remitting multiple sclerosis (RRMS).
- Trial name
- NCT02428218
- Testing
- dimethyl fumarate
- Sponsor
- Biogen
ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia)
PRAISE-IR Versus CIBMTR Controls
The rationale to conduct this RWE study is to provide data to support the safety of CD34 selected grafts versus T replete PBSC transplants to address concerns about increased TRM in CD34 selected graft recipients.
- Conditions
- ALL (Acute B-Lymphoblastic Leukemia), AML (Acute Myeloid Leukemia), MDS (Myelodysplastic Syndrome)
- Trial name
- NCT07717164
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Miltenyi Biomedicine GmbH
Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet…
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Trial name
- NCT04485104
- Testing
- GWP42003-P
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals
Lung Diseases, Interstitial (in Pediatric Populations), Childhood Interstitial Lung Disease (chILD)
A Treatment Protocol to Support the Care of Children and Adolescents With Fibrosing Interstitial Lung Disease (ILD)
This Expanded Access Program (EAP) is intended to facilitate the availability of OFEV® (nintedanib) to children and adolescents with chronic fibrosing interstitial lung disease (ILD) on top of current standard of care treatment…
- Trial name
- NCT05624281
- Testing
- nintedanib
- Sponsor
- Boehringer Ingelheim