Clinical trials: Pediatric Population
Transfusional Iron Overload, Beta-Thalassemia
Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload
This is an open-label study to assess the pharmacokinetics, safety, efficacy and tolerability of SSP-004184AQ. The study consists of two phases: the pharmacokinetic phase, using a single 16 mg/kg dose of SSP-004184AQ; and the…
- Trial name
- NCT01363908
- Testing
- SPD602
- Where
- 9 sites in United States, Canada and 3 more
- Volunteers
- 30 people
- Sponsor
- Shire
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.
Type 1 Diabetes Mellitus
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Children and Adolescents With Type 1 Diabetes
The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog) in children and adolescents with type 1 diabetes (T1D).
- Trial name
- PRONTO-Peds (NCT03740919)
- Testing
- LY900014, Insulin Lispro, Insulin Glargine
- Where
- 111 sites in United States, Austria and 16 more
- Volunteers
- 751 people
- Sponsor
- Eli Lilly and Company
Appendicitis
Transversus Abdominis Plane (TAP) Versus Local Anesthetic for Lap Appendectomies
This study is a prospective, double-blinded, randomized comparison of 2 patient cohorts. One group of patients will receive a transversus abdominis plane (TAP) block.
- Trial name
- NCT01575028
- Testing
- Ropivacaine, Bupivacaine
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Nationwide Children's Hospital
Functional Constipation (FC), Chronic Idiopathic Constipation (CIC)
A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, With Functional Constipation
Functional constipation (FC) is a common healthcare problem in children of all ages, potentially due to genetic predisposition, inadequate fiber and fluid intake, and immobility.
- Trial name
- NCT05652205
- Testing
- Linaclotide
- Where
- 48 sites in United States, Bulgaria and 2 more
- Volunteers
- 123 people
- Sponsor
- AbbVie
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
Fibromyalgia
Adolescent Fibromyalgia Study
This study will compare pregabalin with placebo over a 15 week period in adolescents with fibromyalgia aged 12-17 years to evaluate the safety and efficacy of pregabalin.
- Trial name
- NCT01020474
- Testing
- pregabalin (Lyrica)
- Where
- 36 sites in United States, Czechia and 2 more
- Volunteers
- 107 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Relapsing-Remitting Multiple Sclerosis
Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric participants with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and…
- Trial name
- CONNECT (NCT02283853)
- Testing
- dimethyl fumarate, Interferon β-1a
- Where
- 62 sites in United States, Belgium and 16 more
- Volunteers
- 156 people
- Sponsor
- Biogen
Postoperative Nausea and Vomiting
Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
The objective of the study is to assess the safety and efficacy of two doses of IV palonosetron each administered as a single dose for the prevention of postoperative nausea and vomiting through 72 hours postoperatively in…
- Trial name
- NCT00828295
- Testing
- palonosetron
- Where
- 13 sites in Russia, Ukraine
- Volunteers
- 150 people
- Sponsor
- Helsinn Healthcare SA
Acne
Musculoskeletal Effects of Isotretinoin During Acne Treatment in Pediatric Population
This is a prospective study, that will follow participants over their course of treatment on Isotretinoin. All patients who are prescribed Isotretinoin for their acne treatment are registered in iPLEDGE.
- Trial name
- NCT00964119
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of Wisconsin, Madison
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
Blood Loss, Surgical
Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants
The objective of this study is to assess the safety and immunogenicity of recombinant thrombin (rThrombin) administered as an aid to hemostasis during burn wound excision and skin grafting in pediatric patients, newborn through…
- Trial name
- NCT00859547
- Testing
- rThrombin, 1000 IU/mL
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- ZymoGenetics
Oesophagitis, Eosinophilic
Intravenous Mepolizumab In Children With Eosinophilic Esophagitis
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.
- Trial name
- NCT00358449
- Testing
- mepolizumab
- Where
- 29 sites in United States, Australia and 2 more
- Volunteers
- 84 people
- Sponsor
- GlaxoSmithKline
Bronchospasm, Activity/Exercise Induced Bronchospasm
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test…
- Trial name
- NCT00118716
- Testing
- Fluticasone propionate/salmeterol, Fluticasone Propionate
- Where
- 50 sites in United States
- Volunteers
- 248 people
- Sponsor
- GlaxoSmithKline
Schizophrenia, Bipolar I Disorder
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Sublingual Asenapine in a Pediatric Population With Schizophrenia or Bipolar I Disorder (P06522 AM1)
This study is an open label, sequential-group, two site, multiple dose escalating study of sublingual administered asenapine in a pediatric population with schizophrenia or bipolar I disorder; in one study cohort (3a)…
- Trial name
- NCT01206517
- Testing
- Asenapine 2.5 mg, Asenapine 5 mg, Asenapine 10 mg
- Volunteers
- 30 people
- Sponsor
- Organon and Co
Gastroesophageal Reflux
Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)
The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of…
- Trial name
- NCT00992589
- Testing
- Rabeprazole sodium 5 mg, Rabeprazole sodium 10 mg
- Where
- 81 sites in United States, Australia and 8 more
- Volunteers
- 344 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Influenza, Influenza Immunisation
H3N2 M2SR in Pediatric Population
This is a Phase I double-blind, randomized, placebo-controlled study in 50 healthy adolescents and children, 9-17 years of age, inclusive, who are in good health and meet all eligibility criteria.
- Trial name
- NCT03553940
- Testing
- Influenza Virus Monovalent A/H3N2/Bris 10 M2SR Live Vaccine, Quadrivalent MDCK Inactivated Influenza Vaccine
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Chemotherapy-Induced Nausea and Vomiting
Efficacy and Safety of Palonosetron Intravenous in Prevention of Chemotherapy Induced Nausea and Vomiting in Pediatric Patients
The primary objective is to evaluate the efficacy of two different doses of IV palonosetron in the prevention of chemotherapy induced nausea and vomiting in MEC and HEC patients through 120 hours after start of chemotherapy in…
- Trial name
- NCT01442376
- Testing
- Palonosetron, Ondansetron
- Where
- 67 sites in United States, Argentina and 14 more
- Volunteers
- 502 people
- Sponsor
- Helsinn Healthcare SA
Hemophilia A
Russian Kogenate Pediatric Study
A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.
- Trial name
- NCT00632814
- Testing
- rFVIII-FS (Kogenate FS, BAY14-2222) 70 IU/kg, dosing once per week, rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg twice per week (30 IU/kg + 40 IU/kg), rFVIII-FS (Kogenate FS, BAY14-2222) 75 IU/kg, dosing three times per week (3 x 25 IU/kg)
- Where
- 4 sites in Russia
- Volunteers
- 32 people
- Sponsor
- Bayer
Hypertension
Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)
This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.
- Trial name
- NCT00756938
- Testing
- losartan potassium
- Volunteers
- 101 people
- Sponsor
- Organon and Co