Clinical trials: Pediatric Disease
Diabetes Mellitus
Observational Study to Evaluate the Effectiveness and Safety of the Dexcom G4 Continuous Glucose Monitoring System in Pediatrics
The purpose of this study is to evaluate the effectiveness and safety of the Dexcom G4 System when used as an adjuvant to blood glucose testing over a 7-day period in people 2 to 17 years-old with diabetes mellitus.
- Trial name
- NCT02363907
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- DexCom, Inc.
HIV Infections
Emtricitabine Given Once A Day With Other Anti-HIV Drugs in Children With HIV
The purpose of this study is to see if emtricitabine is safe in children infected with HIV and to determine the best dose.
- Trial name
- NCT00017992
- Testing
- Lopinavir/Ritonavir, Emtricitabine, Stavudine
- Where
- 14 sites in United States, Argentina and 4 more
- Volunteers
- 100 people
- Sponsor
- Triangle Pharmaceuticals
Inflammatory Bowel Diseases
An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease
The purpose of this study is to evaluate whether trough serum infliximab concentrations at the time of loss of clinical response will identify pediatric participants with inflammatory bowel disease (IBD) who would benefit (regain…
- Trial name
- ADAPT (NCT02566889)
- Testing
- Infliximab
- Where
- 36 sites in United States, Canada
- Volunteers
- 53 people
- Sponsor
- Janssen Scientific Affairs, LLC
Genu Varum, Genu Valgum
Retrospective Evaluation of Guided Growth Plate System Plus's Safety and Clinical Performance for the Treatment of Lower Limbs Deformities.
Orthofix is conducting this retrospective Post-market clinical follow up (PMCF) study to assess the safety and clinical performance of the Guided Growth Plate System Plus (GGPSP) device, which is a new version of the Guided…
- Conditions
- Genu Varum, Genu Valgum, Joint Diseases, Knee Deformity
- Trial name
- NCT05241691
- Testing
- Guided Growth Plate System Plus
- Where
- Italy
- Volunteers
- 69 people
- Sponsor
- Orthofix s.r.l.
Crohn's Disease
Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806
This was a multicenter, open-label study to evaluate the human monoclonal anti-TNF-α antibody adalimumab as an effective therapy for maintaining clinical response in pediatric participants with Crohn's disease (CD) and to gather…
- Trial name
- NCT00686374
- Testing
- Adalimumab
- Volunteers
- 100 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Diabetes Mellitus
FreeStyle Libre 2 Flash Glucose Monitoring System Control Phase Study for Pediatric Patients - BG
This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of self-monitoring of blood glucose (SMBG) when used to manage diabetes in pediatric patients.
- Trial name
- NCT04577976
- Testing
- SMBG
- Where
- 2 sites in United States
- Volunteers
- 62 people
- Sponsor
- Abbott Diabetes Care
Atopic Dermatitis
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
Open-Label Study designed to evaluate the HPA axis suppression potential of Clobetasol Topical Oil and pharmacokinetic safety / systemic exposure to clobetasol when Clobetasol Topical Oil is applied to pediatric subjects with…
- Trial name
- NCT03847389
- Testing
- Clobetasol propionate 0.05% Topical Oil
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Hill Dermaceuticals, Inc.
Biliary Atresia
Obeticholic Acid in Pediatric Subjects With Biliary Atresia
This is a Phase 2, multicenter, open-label, single dose and multi-dose, dose-finding study with an optional open-label extension (OLE) to assess the safety, tolerability, and pharmacokinetics of obeticholic acid (OCA) in…
- Trial name
- CARE (NCT05321524)
- Testing
- OCA 0.1mg, OCA 1.5mg, OCA 5mg
- Where
- 17 sites in Belgium, France and 7 more
- Volunteers
- 7 people
- Sponsor
- Intercept Pharmaceuticals
Autistic Disorder, Autism
Withdrawal Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified Previously Treated With Memantine
The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder…
- Conditions
- Autistic Disorder, Autism, Asperger's Disorder, Asperger Syndrome
- Trial name
- NCT01592747
- Testing
- Memantine Hydrochloride (HCl)
- Where
- 94 sites in United States, Belgium and 13 more
- Volunteers
- 479 people
- Sponsor
- Forest Laboratories
Lennox Gastaut Syndrome
Carisbamate Safety Study in Adult and Pediatric Subjects With Lennox-Gastaut Syndrome
Open-label extension study from YKP509C001 to evaluate the safety and tolerability of carisbamate in subjects with Lennox-Gastaut Syndrome (LGS).
- Trial name
- NCT04062981
- Testing
- Carisbamate
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- SK Life Science, Inc.
Diabete Mellitus
FreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations
This study is a non-randomized, single-arm, multi-center study that is designed to evaluate the safety and effectiveness of the FreeStyle Libre Flash Glucose Monitoring Systems in pediatric populations.
- Trial name
- NCT03369899
- Testing
- FreeStyle Libre Flash Glucose Monitoring System
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Abbott Diabetes Care
Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP
A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura
This is an extension study designed to assess the safety and durability of platelet count increases with romiplostim treatment of thrombocytopenic patients with immune (Idiopathic) thrombocytopenia purpura.
- Trial name
- NCT01071954
- Testing
- Romiplostim
- Where
- 31 sites in United States, Australia and 2 more
- Volunteers
- 66 people
- Sponsor
- Amgen
Peanut Allergy
Safety of Epicutaneous Immunotherapy for the Treatment of Peanut Allergy
The purpose of this phase 1b study is to evaluate the safety and tolerability of repeated epicutaneous applications of peanut proteins using a patch delivery system (Viaskin device) in peanut allergic subjects.
- Trial name
- NCT01170286
- Testing
- Whole peanut extract
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- DBV Technologies
Migraine
A Comparison of the Efficacy and Safety of Topiramate Versus Placebo in Preventing Migraine Headaches in Children
The purpose of this study is to assess the safety and efficacy of topiramate as compared to placebo in preventing migraines in children.
- Trial name
- NCT00237302
- Testing
- topiramate
- Volunteers
- 162 people
- Sponsor
- Ortho-McNeil Neurologics, Inc.
HIV Infections
An Open-Label, Non-Randomized Trial to Evaluate the Tolerability and Safety of Viramune (Nevirapine) in Adult and Pediatric Patients With Progressive HIV Disease
To provide access to Viramune and to evaluate the tolerance and safety of Viramune in patients with progressive, symptomatic HIV disease who failed or are intolerant to currently approved treatment for HIV-1 infection and who are…
- Trial name
- NCT00002166
- Testing
- Nevirapine
- Where
- United States
- Sponsor
- Boehringer Ingelheim
Yellow Fever Immunization
A Phase III Control Study of the Safety and Immunogenicity of vYF in Pediatric Population
The purpose of this study is to determine whether vYF (investigational vaccine) is safe and can help the body to develop antibodies (immunogenicity) compared with Stamaril vaccine and YF-VAX vaccine (both licensed vaccines) and…
- Trial name
- NCT07103148
- Testing
- Yellow fever vaccine (live), Measles, combinations with mumps and rubella, live attenuated
- Where
- 15 sites in Honduras, Mexico and 1 more
- Volunteers
- 2,440 people, healthy volunteers welcome
- Sponsor
- Sanofi
Seizures
Cannabidiol Oral Solution in Pediatric Participants With Treatment-resistant Seizure Disorders
This is a Phase 1/2, open-label trial designed to assess the pharmacokinetics, safety, tolerability, and preliminary efficacy of 3 multiple ascending doses of Cannabidiol Oral Solution in a sequential fashion.
- Trial name
- NCT02324673
- Testing
- Cannabidiol Oral Solution
- Where
- 10 sites in United States
- Volunteers
- 61 people
- Sponsor
- INSYS Therapeutics Inc
Epilepsies, Partial
A Phase III Open-Label Extension Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Examine the safety and efficacy of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
- Trial name
- NCT00620555
- Testing
- gabapentin
- Where
- 22 sites in Japan
- Volunteers
- 65 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Epilepsy, Dravet Syndrome
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of TAK-935 (OV935) as an Adjunctive Therapy in Pediatric Participants With Developmental and/or Epileptic Encephalopathies
The purpose of this study is to investigate the effect on the frequency of all seizures (convulsive and drop) in participants treated with TAK-935 compared to placebo.
- Conditions
- Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
- Trial name
- ELEKTRA (NCT03650452)
- Testing
- TAK-935
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 141 people
- Sponsor
- Takeda
Lysosomal Acid Lipase Deficiency
Lysosomal Acid Lipase Deficiency in Risk Groups
A multicenter real-world observational study of the prevalence, diagnostic pathways, and clinical characteristics of lysosomal acid lipase deficiency in pediatric and adolescent risk groups in the Russian Federation (HELIOS)
- Trial name
- HELIOS (NCT07455864)
- Where
- 2 sites in Russia
- Volunteers
- 25 people
- Sponsor
- AstraZeneca
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