Clinical trials: Pediatric Population
Seasonal Allergic Rhinitis (SAR)
Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).
- Trial name
- GSP 301-305 (NCT03463031)
- Testing
- GSP 301 NS
- Where
- 32 sites in United States
- Volunteers
- 446 people
- Sponsor
- Glenmark Specialty S.A.
Hemorrhage
TachoSil® Versus Surgicel® Original for the Secondary Treatment of Local Bleeding in Adult and Pediatric Patients Undergoing Hepatic Resection Surgery
The efficacy and safety of TachoSil® as secondary hemostatic treatment in hepatic resection surgery will be compared to the standard USA licensed hemostatic agent, Surgicel® Original.
- Trial name
- NCT01192022
- Testing
- TachoSil®, Surgicel® Original
- Where
- 17 sites in United States
- Volunteers
- 253 people
- Sponsor
- Takeda
Traumatic Femur Fracture
Femoral Nerve Block for Femur Fracture Repair in Pediatrics
The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing traumatic femur fracture repair who have received either a femoral nerve block with a lateral femoral cutaneous…
- Trial name
- NCT01759407
- Testing
- Ropivicaine, Epinephrine
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Nationwide Children's Hospital
Epilepsy With Partial-onset Seizures
Efficacy and Safety of Lacosamide as Adjunctive Therapy in Subjects ≥1 Month to <4 Years With Partial-onset Seizures
The purpose of this trial is to assess the efficacy, safety and tolerability of lacosamide administered as add-on therapy with 1 to 3 anti-seizure medications.
- Trial name
- NCT02477839
- Testing
- Lacosamide
- Where
- 88 sites in United States, Argentina and 24 more
- Volunteers
- 255 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Sickle Cell Disease, Thalassemia
Hydroxyurea Therapy: Optimizing Access in Pediatric Populations Everywhere
Primary Objective 1. Define the pharmacokinetics of liquid-formulated HU in infants (9 months to <2 years) 2. Assess the relative bioavailability of HU "sprinkles" compared to capsules in children and adolescents (≥2 to 18…
- Trial name
- NCT03825341
- Testing
- Hydroxyurea, Hydroxyurea Oral Capsule
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- St. Jude Children's Research Hospital
Trichuris Infection, Helminthiasis
Albendazole Plus High Dose Ivermectin for Trichuriasis in Pediatric Patients
There are four species of intestinal worms collectively known as soil-transmitted helminthiasis (STH): Ancylostoma duodenale and Necator americanus (hookworms), Ascaris lumbricoides (roundworms), and Trichuris trichiura…
- Trial name
- HI4T (NCT04041453)
- Testing
- Ivermectin, Albendazole
- Where
- 2 sites in Argentina, Honduras
- Volunteers
- 176 people
- Sponsor
- Alejandro Krolewiecki
Psoriasis, Atopic Dermatitis
Study to Evaluate Effect of Pandel Cream 0.1% on HPA Axis in Pediatric and Adult Population
The purpose of this study is to determine the effect of Pandel® (hydrocortisone probutate cream) Cream 0.1% on the Hypothalamic Pituitary Adrenal (HPA) axis in pediatric and adult subjects with either psoriasis or atopic…
- Trial name
- NCT01137032
- Testing
- Pandel Cream 0.1%
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Fougera Pharmaceuticals Inc.
H3N2 Influenza
Assess the Safety and Immunogenicity of One or Two Doses of Sing2016 M2SR H3N2 Influenza Vaccine
This is a Phase 1b, randomized, double-blind, dose-escalating, age de-escalating, placebo-controlled study of 200 children, ages 6 months to 17 years.
- Trial name
- NCT04960397
- Testing
- Sing2016 M2SR H3N2
- Where
- 4 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Dehydration, Cardiac Output
Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics
The purpose of this study is to non-invasively study the reflective changes in cardiac output as response to fluid therapy in the pediatric moderate hypovolemia/dehydrated pediatric patients using sub-q rehydration using Hylenex…
- Conditions
- Dehydration, Cardiac Output, Pediatrics
- Trial name
- Hylenex (NCT01139294)
- Testing
- Hylenex
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Vanderbilt University Medical Center
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.
Moderate-to-Severe Atopic Dermatitis
Pharmacokinetics, Safety and Efficacy of Nemolizumab in Participants With Moderate-to-Severe Atopic Dermatitis
The purpose of this study was to assess the pharmacokinetics (PK), safety, and efficacy of nemolizumab in pediatric participants with moderate-to-severe atopic dermatitis (AD).
- Trial name
- NCT04921345
- Testing
- Nemolizumab
- Where
- 23 sites in United States, Denmark and 3 more
- Volunteers
- 109 people
- Sponsor
- Galderma R&D
Sore-throat, Cough
The Performance and Safety of Petit Drill in the French Paediatric Population: a Post-market Clinical Follow-up Study
Demulcent or soothing substance is the currently recommended option to alleviate throat irritation associated to cough and sore throat in children under 6 years.
- Trial name
- Touxpetit (NCT06688370)
- Testing
- Petit Drill
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Pierre Fabre Medicament
Helminth Infections
A Study to Assess the Efficacy and Safety of Mebendazole for the Treatment of Helminth Infections in Pediatric Participants
The purpose of this study is to evaluate the efficacy and safety of mebendazole compared with placebo in pediatric participants with Helminth infections.
- Trial name
- NCT02034162
- Testing
- Mebendazole
- Where
- 3 sites in Ethiopia, Rwanda
- Volunteers
- 295 people
- Sponsor
- Janssen Research & Development, LLC
Allergic Conjunctivitis
Evaluation of the Safety and Pharmacokinetics of Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Combination Ophthalmic Solution
To compare the safety and tolerability of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% combination ophthalmic solution versus its vehicle in healthy adult subjects and in pediatric subjects.
- Trial name
- NCT05815758
- Testing
- Brimonidine Tartrate 0.025%/Ketotifen Fumarate 0.035% Ophthalmic Solution (Combo), Vehicle of brimonidine tartrate 0.025%/ketotifen fumarate 0.035% ophthalmic solution
- Where
- 7 sites in United States
- Volunteers
- 512 people, healthy volunteers welcome
- Sponsor
- Bausch & Lomb Incorporated
Encephalopathy, Birth Defect
Clinical Utility of Pediatric Whole Exome Sequencing
The investigator aims to examine the clinical utility of WES, including assessment of a variety of clinical outcomes in undiagnosed pediatric cases.
- Conditions
- Encephalopathy, Birth Defect, Intellectual Disability, Multiple Congenital Anomaly
- Trial name
- NCT03525431
- Testing
- Whole Exome Sequencing
- Where
- 4 sites in United States
- Volunteers
- 529 people
- Sponsor
- University of California, San Francisco
Functional Constipation, Irritable Bowel Syndrome With Constipation
Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)
The objective of LIN-MD-64 is to evaluate the safety and efficacy of 12 weeks of linaclotide therapy (72 μg daily) in comparison with placebo in pediatric participants, 6 to 17 years of age, who fulfill modified Rome III Criteria…
- Trial name
- NCT04026113
- Testing
- Linaclotide
- Where
- 115 sites in United States, Belgium and 12 more
- Volunteers
- 438 people
- Sponsor
- AbbVie
Pain, Postoperative
Analgesic Efficacy of Repeated Doses of Intravenous (IV) Acetaminophen in Post-operative Pediatric Spine Fusion Patients
This is a prospective, randomized, double-blinded, placebo controlled trial Potential subjects will be identified from the Pre-Surgical Anesthesia Clinic visit.
- Trial name
- IV APAP SF (NCT01394718)
- Testing
- Intravenous Acetaminophen
- Where
- United States
- Volunteers
- 67 people
- Sponsor
- Children's Hospital of Philadelphia
Unilateral Cataract Extraction, Congenital Cataract
A Randomized Study in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
The purpose of this study is to evaluate the effect of OMS302 compared to phenylephrine when administered in irrigation solution during cataract extraction on intraoperative pupil diameter, acute postoperative pain, and safety in…
- Trial name
- ILR7 (NCT02132312)
- Testing
- OMS302, Phenylephrine HCl
- Where
- 11 sites in United States
- Volunteers
- 78 people
- Sponsor
- Omeros Corporation
Overactive Bladder, Voiding Disorders
Feasibility of Parasacral Transcutaneous Electrical Nerve Stimulation PTENS for Voiding Dysfunction in Peds Population
Pilot study for determining feasibility of home parasacral transcutaneous electrical nerve stimulation in treatment of urinary urgency and incontinence.
- Conditions
- Overactive Bladder, Voiding Disorders, Incontinence, Urinary
- Trial name
- NCT04570605
- Testing
- parasacral transcutaneous electrical nerve stimulation (PTENS), Standard Urotherapy
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Utah