Clinical trials: Pediatric Patients
Acute Kidney Injury in Pediatric Patients
Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children
The primary objective of this study is to evaluate the efficacy of the Gambro Prismaflex® HF20 Set based on testing the hypothesis that it delivers sufficient renal replacement therapy to effectively treat acute kidney injury…
- Trial name
- NCT02561247
- Testing
- Prismaflex HF20 CRRT Filter, Prismaflex® System 7.10 and 7.20
- Where
- 6 sites in United States
- Volunteers
- 23 people
- Sponsor
- Vantive Health LLC
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
Post Operative Ileus
Chewing Gum Use to Reduce Post-operative Ileus in Pediatric Patients
Post- operative ileus refers to the time after surgery before coordinated electromotor bowel function resumes. It's treatment and prevention may signify an elevated hospitalization cost and the exposure to the patient to adverse…
- Trial name
- NCT01583452
- Testing
- Chewing Gum
- Where
- Mexico
- Volunteers
- 41 people
- Sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
Grade B Acute Graft Versus Host Disease, Grade C Acute Graft Versus Host Disease
Safety Follow-up of Treatment With Remestemcel-L in Pediatric Participants Who Have Failed to Respond to Steroid Treatment for Acute GVHD
Ongoing safety assessment follow-up to Protocol MSB-GVHD001 (NCT02336230) of remestemcel-L treatment in pediatric participants with acute graft versus host disease (aGVHD), following allogeneic hematopoietic stem cell transplant…
- Conditions
- Grade B Acute Graft Versus Host Disease, Grade C Acute Graft Versus Host Disease, Grade D Acute Graft Versus Host Disease
- Trial name
- NCT02652130
- Testing
- Remestemcel-L
- Where
- 20 sites in United States
- Volunteers
- 32 people
- Sponsor
- Mesoblast, Inc.
Migraine
A Study to Test if Fremanezumab is Effective in Preventing Episodic Migraine in Patients 6 to 17 Years of Age
The primary objective of the study is to evaluate the efficacy of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM).
- Trial name
- NCT04458857
- Testing
- Fremanezumab
- Where
- 89 sites in United States, Canada and 7 more
- Volunteers
- 235 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Major Depressive Disorder
Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder
The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD).
- Trial name
- NCT03569475
- Testing
- Levomilnacipran ER, Fluoxetine
- Where
- 51 sites in United States
- Volunteers
- 501 people
- Sponsor
- Allergan
Primary Fibromyalgia
Safety and Efficacy of Milnacipran in Pediatric Patients With Primary Fibromyalgia
The purpose of this study is to evaluate the safety, tolerability, efficacy, and pharmacokinetics of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.
- Trial name
- MyFi (NCT01328002)
- Testing
- Milnacipran
- Where
- 47 sites in United States
- Volunteers
- 116 people
- Sponsor
- Forest Laboratories
Obstructive Sleep Apnea
Comparing Auto-adjustable Positive Airway Pressure to Continuous Positive Airway Pressure in Children With Sleep Apnea
The purpose of this research study is to determine if auto-adjustable positive airway pressure (APAP) is an effective way to treat obstructive sleep apnea (OSA) in children.
- Trial name
- NCT01846988
- Testing
- crossover treatment (REMstar Auto A-Flex)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Diabetes Mellitus, Type 2 Diabetes
Study to Assess Safety & Efficacy of Sitagliptin as Initial Oral Therapy for Treatment of Type 2 Diabetes Mellitus in Pediatric Participants. (MK-0431-083)
The purpose of the study is to assess the safety of the addition of sitagliptin, and its effect on hemoglobin A1c (A1C) in pediatric participants 10-17 years of age with type 2 diabetes mellitus (T2DM) with inadequate glycemic…
- Trial name
- NCT01485614
- Testing
- Sitagliptin, Metformin, Glycemic Rescue 1
- Volunteers
- 200 people
- Sponsor
- Merck Sharp & Dohme LLC
Ventricular Tachycardia, Ventricular Fibrillation
Pediatric Lead Extractability and Survival Evaluation (PLEASE)
This is a randomized, prospective clinical trial comparing 2 different types of implantable cardioverter defibrillator (ICD) leads in children and patients with congenital heart disease.
- Conditions
- Ventricular Tachycardia, Ventricular Fibrillation, Cardiomyopathy, Long QT Syndrome
- Trial name
- NCT00335036
- Testing
- ICD lead implant, Thin leads
- Where
- United States
- Volunteers
- 748 people
- Sponsor
- Charles Berul
Pediatric Safety and Effectiveness
Vfend Special Investigation For Pediatric - Observational
Examine the safety and effectiveness of Vfend [voriconazole] for pediatric under general clinical practices.
- Trial name
- NCT02554656
- Where
- Japan
- Volunteers
- 89 people
- Sponsor
- Pfizer
Aplastic Anemia
A Phase II Dose-escalation Study Characterizing the PK of Eltrombopag in Pediatric Patients With Previously Untreated or Relapsed Severe Aplastic Anemia or Recurrent Aplastic Anemia
This is a phase II, open label, multi-center, intra-patient dose escalation study to characterize the pharmacokinetics (PK) after oral administration of eltrombopag in combination with immunosuppressive therapy in pediatric…
- Trial name
- NCT03025698
- Testing
- Eltrombopag, hATG, CsA
- Where
- 20 sites in United States, Hong Kong and 4 more
- Volunteers
- 51 people
- Sponsor
- Novartis Pharmaceuticals
Crohn's Disease
High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children
The purpose of this 4 week study is to determine whether PASER®, an approved delayed-release oral formulation of 4-aminosalicylic acid, in doses of 50 milligrams per kilogram three times daily for 2 weeks followed by 50…
- Trial name
- NCT00495521
- Testing
- 4-Aminosalicylic acid extended release granules
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Jacobus Pharmaceutical
Burns, Sedation
Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients
Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.
- Trial name
- NCT00697788
- Testing
- Dexmedetomidine
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Massachusetts General Hospital
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
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
Epilepsies, Partial
A Phase III Open-Label Study Of Gabapentin As Adjunctive Therapy In Japanese Pediatric Patients With Partial Seizures
Examine the efficacy, safety and pharmacokinetics of gabapentin as adjunctive therapy in Japanese pediatric patients with partial seizures
- Trial name
- NCT00603473
- Testing
- gabapentin
- Where
- 26 sites in Japan
- Volunteers
- 92 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Medulloblastoma, Rhabdomyosarcoma
A Phase I Dose Finding and Safety Study of Oral LDE225 in Children and a Phase II Portion to Assess Preliminary Efficacy in Recurrent or Refractory MB
Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in children with recurrent or refractory medulloblastoma, or other…
- Conditions
- Medulloblastoma, Rhabdomyosarcoma, Neuroblastoma, Hepatoblastoma
- Trial name
- NCT01125800
- Testing
- LDE225
- Where
- 14 sites in United States, Australia and 4 more
- Volunteers
- 76 people
- Sponsor
- Novartis Pharmaceuticals
Migraine
A Trial to Test if Fremanezumab is Effective in Preventing Migraine in Children and Adolescents
The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment…
- Trial name
- NCT04530110
- Testing
- Fremanezumab
- Where
- 70 sites in United States, Canada and 7 more
- Volunteers
- 499 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Muscular Dystrophy, Duchenne
Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy
The PolarisDMD study is a Phase 3, global study to evaluate the efficacy and safety of edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD.
- Trial name
- PolarisDMD (NCT03703882)
- Testing
- Edasalonexent
- Where
- 40 sites in United States, Australia and 6 more
- Volunteers
- 131 people
- Sponsor
- Catabasis Pharmaceuticals