Clinical trials: Pediatric Safety and Effectiveness
Hereditary Angioedema (HAE)
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in…
- Trial name
- NCT01386658
- Testing
- icatibant
- Where
- 26 sites in United States, Australia and 8 more
- Volunteers
- 32 people
- Sponsor
- Shire
Bacteremia
Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)
The intent of this study is to describe the safety and efficacy of daptomycin versus standard of care (SOC) in pediatric participants aged 1-17 years with bacteremia caused by Staphylococcus aureus (S. aureus).
- Trial name
- NCT01728376
- Testing
- Daptomycin, Comparator
- Volunteers
- 82 people
- Sponsor
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Glycogen Storage Disease Type II-Pompe's Disease
A Study to Assess Safety and Efficacy of Avalglucosidase Alfa Administered Every Other Week in Pediatric Patients With Infantile-onset Pompe Disease Previously Treated With Alglucosidase Alfa
This is a multi-stage, phase 2, open-label, multicenter, multinational, ascending dose cohort, repeated intravenous (IV) infusion study of avalglucosidase alfa in pediatric patients with Infantile-Onset Pompe Disease (IOPD) who…
- Trial name
- Mini-COMET (NCT03019406)
- Testing
- Avalglucosidase alfa (GZ402666), Alglucosidase alfa (GZ419829)
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Pediatric Nursing
The Effect of Digital and Classical Education Based on Planned Behavior Theory Given to Mothers in the Risk Group on Their Self-Efficacy in Identifying Safety Measures and First Aid for Home Accidents
Childhood home accidents are a significant health problem in our country and the world. Home accidents are more common in children aged 1-5, and cause temporary and permanent disabilities in deaths.
- Trial name
- Home Accidents (NCT06981416)
- Testing
- Digital education group, classical education group
- Where
- Turkey (Türkiye)
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Selcuk University
Systemic Juvenile Idiopathic Arthritis
Study to Evaluate the Safety and Tolerability of Two Doses of Rilonacept in Pediatric Subjects With Active Systemic Juvenile Idiopathic Arthritis (SJIA)
This study is a pilot, ascending dose, multi-center, randomized, double blind, placebo controlled, pediatric study conducted in three phases.
- Trial name
- NCT01803321
- Testing
- rilonacept (IL-1 Trap)
- Where
- 9 sites in United States
- Volunteers
- 24 people
- Sponsor
- Regeneron Pharmaceuticals
Lymphatic Malformation
Use of Bleomycin in the Sclerotherapy of Lymphatic Malformations for Pediatric Patients
Bleomycin has nowadays been more and more widely used in the sclerotherapy of LMs, which has been proven to be primarily dose dependent.
- Trial name
- NCT06437158
- Testing
- Bleomycin
- Where
- China
- Volunteers
- 200 people
- Sponsor
- West China Hospital
Atopic Dermatitis
Double-Blind, Trial to Evaluate the Safety and Efficacy of MRX-6 Cream 2%
Randomized, double-blind, parallel group, placebo-controlled, multicenter, efficacy and safety study in subjects with mild to moderate atopic dermatitis.
- Trial name
- C012013 (NCT02031445)
- Testing
- MRX-6
- Where
- 5 sites in Israel
- Volunteers
- 73 people
- Sponsor
- Celsus Therapeutics PLC
Vasculitis
Study to Evaluate Avacopan in Combination With a Rituximab or Cyclophosphamide-containing Regimen, in Children From 6 Years to < 18 Years of Age With AAV.
The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV.
- Trial name
- NCT06321601
- Testing
- Avacopan
- Where
- 34 sites in United States, Belgium and 8 more
- Volunteers
- 19 people
- Sponsor
- Amgen
Acute Otitis Media
Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and effective in treating middle ear infections in children with ear tubes.
- Trial name
- NCT01395966
- Testing
- DF289, DF277, DF289 plus DF277
- Where
- Spain
- Volunteers
- 331 people
- Sponsor
- Salvat
Failed Conscious Sedation During Procedure
The Efficacy and the Safety of Dexmedetomidine Sedation on the Pediatric Intensive Unit(PICU) Patients.
To observe the efficacy and safety of dexmedetomidine sedation on the patients admitted to the pediatric intensive care unit after surgery.
- Trial name
- NCT02296073
- Testing
- Midazolam, Dexmedetomidine, Fentanyl
- Volunteers
- 120 people
- Sponsor
- Anhui Provincial Children's Hospital
Neutropenia, Fungal Disease
Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation
This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.
- Trial name
- NCT01417169
- Testing
- micafungin
- Where
- South Korea
- Volunteers
- 112 people
- Sponsor
- Seoul National University Hospital
Acute Pain
A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after initiation of investigational medicinal product…
- Trial name
- NCT02081391
- Testing
- Tapentadol oral solution 4 mg/mL, Tapentadol oral solution 20 mg/mL
- Where
- 43 sites in United States, Bulgaria and 8 more
- Volunteers
- 216 people
- Sponsor
- Grünenthal GmbH
Behçet Disease
Apremilast Pediatric Study in Children With Active Oral Ulcers Associated With Behçet's Disease
The aim of this study is to estimate the efficacy of apremilast compared to placebo in the treatment of oral ulcers in pediatric participants from 2 to < 18 years of age with oral ulcers associated with Behçet's disease (BD)…
- Trial name
- BEAN (NCT04528082)
- Testing
- Apremilast
- Where
- 27 sites in France, Greece and 6 more
- Volunteers
- 60 people
- Sponsor
- Amgen
Urinary Bladder, Overactive
A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076
This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).
- Trial name
- LEOPARD (NCT01655069)
- Testing
- Solifenacin succinate suspension
- Where
- 39 sites in United States, Belgium and 14 more
- Volunteers
- 148 people
- Sponsor
- Astellas Pharma Europe B.V.
Acute Myeloid Leukemia, Accelerated Phase Chronic Myeloid Leukemia
Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias, Lymphomas or Solid Tumors
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ponatinib in children aged 1 to < 18 years with advanced leukemias, lymphomas, and solid tumors.
- Conditions
- Acute Myeloid Leukemia, Accelerated Phase Chronic Myeloid Leukemia, Blast Phase Chronic Myeloid Leukemia, Chronic Phase Chronic Myeloid Leukemia
- Trial name
- NCT03934372
- Testing
- Ponatinib
- Where
- 23 sites in Belgium, France and 5 more
- Volunteers
- 70 people
- Sponsor
- Incyte Biosciences International Sàrl
Food Allergy in Children
Sustained Unresponsiveness (SU) to Sesame Protein Following Low-dose Oral Allergen-specific Immunotherapy
This study is a long-term follow-up of participants from the randomized controlled trial (RCT) "Efficacy and Safety of Low-Dose Sesame Oral Immunotherapy in Pediatric Patients", NCT06261554.
- Trial name
- NCT07107451
- Testing
- OIT with low dose sesame protein
- Where
- Poland
- Volunteers
- 39 people
- Sponsor
- Medical University of Warsaw
Asthma Acute, Exacerbation of Allergic Asthma
Nebulized Ketamine for Severe Asthma Attacks in Children
This is a double-blinded, randomised, placebo-controlled trial enrolling 60 children aged 1 to 13 years with severe asthma exacerbation. All participants will receive standard therapy.
- Trial name
- NCT07728851
- Testing
- Ketamine (1 mg/kg)
- Where
- Oman
- Volunteers
- 60 people
- Sponsor
- Sultan Qaboos University
Proteinuria
Efficacy and Safety of Losartan in Pediatric Chronic Kidney Disease With Tubular Proteinuria
The investigators hypothesize that using Losartan would help decrease proteinuria in pediatric chronic kidney disease with tubular proteinuria.
- Trial name
- NCT02232763
- Testing
- Losartan
- Where
- South Korea
- Volunteers
- 58 people
- Sponsor
- Seoul National University Hospital
Ulcerative Colitis
Vedolizumab in Pediatric Ulcerative Colitis- Comparison With Infliximab
This is a multicenter, double-blind, randomized study to compare the safety, effectiveness and immunogenicity (antibodies against drug) of two biological drugs administered intravenously - vedolizumab (a drug not registered in…
- Trial name
- VEDI-UC (NCT06614387)
- Testing
- Infliximab
- Volunteers
- 60 people
- Sponsor
- JAROSLAW KIERKUS
Fever
A Study of Caldolor in Hospitalized Febrile Pediatric Patients
The primary objective of this study of Caldolor administered to febrile hospitalized pediatric patients every 6 hours for 24 hours is to determine the clinical equivalence of a single dose of Caldolor compared to acetaminophen…
- Trial name
- NCT00225706
- Testing
- Caldolor
- Where
- 3 sites in United States, Panama and 1 more
- Sponsor
- Cumberland Pharmaceuticals
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