Clinical trials: Pediatric Diseases
Hereditary Angioedema (HAE)
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema
Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of…
- Trial name
- NCT02052141
- Testing
- CINRYZE 500, CINRYZE 1000
- Where
- 8 sites in United States, Germany and 3 more
- Volunteers
- 12 people
- Sponsor
- Shire
Neuroblastoma, Rhabdomyosarcoma
Study to Find a Safe Dose and Show Early Clinical Activity of Weekly Nab-paclitaxel in Pediatric Patients With Recurrent/ Refractory Solid Tumors
The purpose of this study is to find the safe dose of nab-paclitaxel in children with solid tumors, and to see if it works to treat these solid tumors in children and young adults (in Phase 1 ≤ 18 years old and in Phase 2 ≤ 24…
- Conditions
- Neuroblastoma, Rhabdomyosarcoma, Ewing's Sarcoma, Ewing's Tumor
- Trial name
- NCT01962103
- Testing
- nab-paclitaxel
- Where
- 20 sites in United States, Canada and 5 more
- Volunteers
- 107 people
- Sponsor
- Celgene
Partial Seizures
A Study to Assess the Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Extension Study)
The purpose of this study is to assess the long-term safety and efficacy of zonisamide used as an adjunctive treatment in pediatric subjects treated with 1 or 2 other anti-epileptic drugs (AEDs).
- Trial name
- NCT01136954
- Testing
- Zonisamide
- Where
- Italy
- Volunteers
- 144 people
- Sponsor
- Eisai Limited
Obsessive-compulsive Disorder
D-Cycloserine Augmentation of Therapy for Pediatric Obsessive-Compulsive Disorder
Cognitive-behavioral therapy (CBT) has proven efficacy for treatment of pediatric obsessive-compulsive disorder (OCD). Yet, CBT does not help all children and those who benefit often remain symptomatic upon treatment completion.
- Trial name
- NCT00864123
- Testing
- Cognitive-behavioral therapy, D-cycloserine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of South Florida
Chronic Iron Overload
Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation
Extend evaluation of deferasirox film-coated tablet (FCT) formulation
- Trial name
- NCT02720536
- Testing
- Deferasirox
- Where
- 14 sites in Austria, Greece and 1 more
- Volunteers
- 53 people
- Sponsor
- Novartis Pharmaceuticals
Anxiety, Lacerations
Intranasal Midazolam for Treatment of Anxiety in Children Undergoing Suturing in the Pediatric Emergency Department
Laceration repair can cause significant anxiety in children. As open wounds account for 21-25% of injuries in children presenting to the emergency department, the management of anxiety is of great importance.
- Trial name
- NCT02618772
- Testing
- Midazolam, Saline
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Obesity, Childhood
Dissemination and Implementation of Improving Pediatric Obesity Practice Using Prompts
The purpose of this study is to evaluate the dissemination and implementation of electronic health record-based clinical decision support tools for the management of pediatric overweight and obesity in primary care.
- Trial name
- iPOP-UP (NCT05627011)
- Testing
- Improving Pediatric Obesity Practice Using Prompts (iPOP-UP)
- Where
- 3 sites in United States
- Volunteers
- 58,364 people
- Sponsor
- Yale University
Venous Thromboembolism (VTE), Pulmonary Embolism
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE.
- Conditions
- Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)
- Trial name
- NCT02798471
- Testing
- Edoxaban, Standard of Care
- Where
- 140 sites in United States, Argentina and 32 more
- Volunteers
- 290 people
- Sponsor
- Daiichi Sankyo
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.
Crohn's Disease
Trial of Growth Hormone Therapy in Pediatric Crohn's Disease
The purpose of this study is to determine whether taking a growth hormone (GH) drug called somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when compared to a person with Crohn's Disease that…
- Trial name
- NCT00109473
- Testing
- growth hormone, cortecosteroid
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Infectious Diseases
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such…
- Trial name
- NCT00761462
- Testing
- Ciprofloxacin, Non-quinolone antibiotic
- Where
- 67 sites in United States, Canada
- Volunteers
- 1,029 people
- Sponsor
- Bayer
Skin Infections, Bacterial
Pharmacokinetics of Retapamulin in Pediatric Subjects With Uncomplicated Skin Infections.
A study to evaluate the pharmacokinetics of Retapamulin Ointment, 1%, in pediatric subjects (2-24 months) with secondarily-infected traumatic lesions, secondarily-infected dermatoses, or impetigo (bullous and non-bullous).
- Trial name
- NCT00555061
- Testing
- Retapamulin Ointment, 1%
- Where
- 25 sites in United States, Argentina and 7 more
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Recurrent and Refractory Solid Tumors
Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors
Phase 1 of this study, utilizing a rolling 6 design, will be conducted to determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), and to describe the toxicities of lenvatinib administered in combination with…
- Trial name
- NCT03245151
- Testing
- Lenvatinib, Everolimus
- Where
- 50 sites in United States, Canada
- Volunteers
- 64 people
- Sponsor
- Eisai Inc.
Cerebral Palsy
Sensory Stimulation During CIMT
The long-term goal of this project is to assess the impact of the novel sensory stimulation technique in enhancing outcomes of constraint-induced movement therapy (CIMT) in children with cerebral palsy. This is a pilot project.
- Trial name
- NCT03558230
- Testing
- Standardized Constraint-Induced Movement Therapy, Vibration
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Medical University of South Carolina
Obesity, Childhood, Overweight and Obesity
First Heroes: Engaging Fathers in the First 1000 Days
The First Heroes study plans to influence weight and health trajectories, modify disease risk, and improve health care services for mother-father-infant triads from racial/ethnic minority and health disparity populations.
- Conditions
- Obesity, Childhood, Overweight and Obesity, Social Determinants of Health, Physical Activity
- Trial name
- First Heroes (NCT04477577)
- Testing
- New Parent Intervention, Safety Control
- Where
- United States
- Volunteers
- 657 people
- Sponsor
- Massachusetts General Hospital
Overactive Bladder (OAB), Pharmacokinetics of Mirabegron
A Study to Evaluate Mirabegron in Pediatric Participants From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
The purpose of this study was to evaluate the efficacy of mirabegron in children (5 to < 12 years of age) with OAB. This study will also evaluated the safety and tolerability of mirabegron in pediatric participants with OAB and…
- Trial name
- Dolphin (NCT04641975)
- Testing
- Mirabegron
- Where
- 15 sites in Belgium, France and 8 more
- Volunteers
- 26 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Hypertriglyceridemia, Pediatric Obesity
Effect of Omega-3 Fatty Acids Supplementation on Hypertriglyceridemia in Pediatric Patients With Obesity.
The primary objective was to evaluate the safety and efficacy the 3 grams per day of omega-3 in adolescents with obesity and hypertriglyceridemia ( ≥ 150 mg/dl and ≤ 1000 mg/dl) for 12 weeks, compared with placebo.
- Trial name
- NCT03216057
- Testing
- Omega-3 fatty acid 3 grams per day
- Volunteers
- 168 people
- Sponsor
- Hospital Infantil de Mexico Federico Gomez
Influenza, Human
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2016/2017 Quadrivalent Influenza Vaccine…
- Trial name
- NCT02914275
- Testing
- Seqirus Quadrivalent Inactivated Influenza Vaccine, Comparator Quadrivalent Inactivated Influenza Vaccine
- Where
- 39 sites in United States
- Volunteers
- 2,250 people, healthy volunteers welcome
- Sponsor
- Seqirus
Lymphoma, Childhood Lymphoma
Study of Genistein in Pediatric Oncology Patients (UVA-Gen001)
Toxicities related to pediatric cancer treatment can lead to significant illness, organ damage, treatment delays, increased health care cost, and decrease in quality of life.
- Conditions
- Lymphoma, Childhood Lymphoma, Solid Tumor, Childhood Solid Tumor
- Trial name
- UVA-Gen001 (NCT02624388)
- Testing
- Genistein
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- University of Virginia
Sarcoma, Metastatic Disease
Stereotactic Radiation Therapy for Pediatric Sarcomas
The stereotactic body radiation therapy (SBRT) literature focuses on clinical outcomes in the adult population. However, SBRT has a particularly strong rationale for application in pediatrics given that high biologically…
- Conditions
- Sarcoma, Metastatic Disease, Bony Sites
- Trial name
- NCT01763970
- Testing
- SBRT
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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