Clinical trials: Paediatric
Dravet Syndrome
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Fenfluramine (Hydrochloride) in Infants 1 Year to Less Than 2 Years of Age With Dravet Syndrome
The primary purpose of this study is evaluate the safety and tolerability of fenfluramine hydrochloride (HCl) 0.2 to 0.8 mg/kg/day in infants 1 year to less than 2 years of age with Dravet syndrome.
- Trial name
- ORCHID (NCT06118255)
- Testing
- fenfluramine
- Where
- 12 sites in United States, Belgium and 3 more
- Volunteers
- 25 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Vernal Keratoconjunctivitis
Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis
The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day…
- Trial name
- NCT01751126
- Testing
- NOVA22007 ''Ciclosporin''
- Where
- 46 sites in United States, Croatia and 9 more
- Volunteers
- 169 people
- Sponsor
- Santen SAS
Congenital Bleeding Disorder, Haemophilia A
A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A
This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who…
- Trial name
- pathfinder™5 (NCT01731600)
- Testing
- turoctocog alfa pegol
- Where
- 51 sites in United States, Brazil and 14 more
- Volunteers
- 68 people
- Sponsor
- Novo Nordisk A/S
Epilepsy, Epilepsy in Children
OASIS: RetrOspective Analysis on EEGs for Identifying Seizure Susceptibility in paediatrIcs Using biomarkerS
The goal of this retrospective study is to validate a set of computational biomarkers (BioEP) for seizure susceptibility on retrospective routinely collected non-contributory EEGs in paediatric participants with epilepsy.
- Trial name
- OASIS (NCT06546410)
- Testing
- BioEP
- Where
- 7 sites in United Kingdom
- Volunteers
- 530 people
- Sponsor
- Neuronostics Ltd
Growth Disorders
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Greece
This is a National, Multicentre, Observational Registry to study adherence and long term outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospitals in Greece and…
- Trial name
- ECOS GRE (NCT01363674)
- Testing
- Easypod™
- Where
- Greece
- Volunteers
- 180 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Venous Thromboembolism
A Study in Europe Based on Medical Records That Looks at the Safety of Dabigatran in Children Below 2 Years of Age Who Have Had a Blood Clot and Are at Risk of Developing Another Blood Clot
The study is designed to collect and evaluate Dabigatran Etexilate (DE) safety in the context of routine anticoagulation care provided in the European Union (EU)/European Economic Area (EEA) for children under 2 years of age.
- Trial name
- DaPaR (NCT05536791)
- Testing
- Dabigatran Etexilate (DE)
- Where
- 6 sites in Germany, Netherlands and 2 more
- Sponsor
- Boehringer Ingelheim
Constipation, Signs and Symptoms, Digestive
Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients
To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.
- Trial name
- NCT02099591
- Testing
- Naloxegol
- Where
- 16 sites in Denmark, Israel and 3 more
- Volunteers
- 61 people
- Sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
Skin Infections, Bacterial
Topical SB-275833 Ointment, 1% For The Treatment Of Impetigo
The goal of this study is to determine if topical SB-275833 ointment, 1% is as safe and effective as topical sodium fusidate ointment, 2% for the treatment of impetigo in adults and children as young as 9 months of age.
- Trial name
- NCT00133874
- Testing
- SB-275833 ointment, 1%
- Where
- 69 sites in Canada, Costa Rica and 8 more
- Volunteers
- 520 people
- Sponsor
- GlaxoSmithKline
Human Immunodeficiency Virus
An Open Label Pharmacokinetic, Safety And Efficacy Study Of Maraviroc In Combination With Background Therapy For The Treatment Of HIV-1 Infected, CCR5 -Tropic Children
The primary purpose of this study is to determine the pharmacokinetic properties (what the body does to maraviroc) and to determine a suitable dosing schedule of maraviroc in HIV-1 infected children and adolescents.
- Trial name
- NCT00791700
- Testing
- Maraviroc
- Where
- 41 sites in United States, Brazil and 7 more
- Volunteers
- 103 people
- Sponsor
- ViiV Healthcare
Diabetes, Diabetes Mellitus, Type 1
Comparison of Insulin Detemir and Insulin Aspart in 2 Separate Injections Twice Daily to Extemporaneous Mixing Injection Regimen Twice Daily - The Paediatric Mixing Trial
This trial is conducted in Europe. The aim of the trial is to compare two methods of injection in basal-bolus insulin regimen in children with type 1 diabetes with insulin detemir associated with insulin aspart given twice daily…
- Trial name
- MIXING (NCT00542620)
- Testing
- insulin detemir, insulin aspart
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Novo Nordisk A/S
Hemorrhage
Reversal Dabigatran Anticoagulant Effect With Idarucizumab
The trial objective is to demonstrate the safety of idarucizumab, as assessed by the occurence of patients with drug related adverse events (including immune reactions) and all-cause mortality in paediatric venous thromboembolism…
- Trial name
- NCT02815670
- Testing
- Idarucizumab
- Where
- 2 sites in Russia
- Volunteers
- 1 people
- Sponsor
- Boehringer Ingelheim
Chronic Kidney Disease, Hyperparathyroidism, Secondary
Study to Evaluate Cinacalcet in Children With Chronic Kidney Disease
The primary objective of the study was to evaluate the safety and tolerability of cinacalcet after a single oral dose in children aged 28 days to less than 6 years with chronic kidney disease receiving dialysis.
- Conditions
- Chronic Kidney Disease, Hyperparathyroidism, Secondary, Secondary Hyperparathyroidism
- Trial name
- NCT01290029
- Testing
- Cinacalcet
- Where
- 10 sites in United States, Germany and 1 more
- Volunteers
- 14 people
- Sponsor
- Amgen
Constipation
Prucalopride in Paediatric Subjects, With Functional Faecal Retention
The purpose of this study is characterize the efficacy, safety, tolerability, and steady-state plasma levels after once-daily oral dosing of prucalopride (R108512) as a solution, 0.01 mg/kg to 0.03 mg/kg, given to paediatric…
- Trial name
- NCT01670669
- Testing
- prucalopride
- Volunteers
- 37 people
- Sponsor
- Movetis
Ulcerative Colitis
A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.
The purpose of this randomized, open-label, parallel-group study is to determine how the body absorbs and eliminates mesalamine following administration of either 30 mg/kg/day, 60 mg/kg/day or 90 mg/kg/day as 400 mg…
- Trial name
- NCT00254618
- Testing
- mesalamine
- Where
- 22 sites in United States
- Volunteers
- 34 people
- Sponsor
- Warner Chilcott
Myopia
Safety and Efficacy of T10430 Eye Drops in Controlling Paediatric Myopia Progression
Axial myopia is a type of nearsightedness that happens when the eye is too long from front to back. This causes distant vision to be blurry.
- Trial name
- NCT07522242
- Testing
- T10430 lower dose, T10430 middle dose, T10430 higher dose
- Where
- 10 sites in Jordan, South Africa and 1 more
- Volunteers
- 200 people
- Sponsor
- Laboratoires Thea
Congenital Bleeding Disorder, Haemophilia A
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.
- Trial name
- pathfinder™6 (NCT02137850)
- Testing
- turoctocog alfa pegol
- Where
- 96 sites in United States, Algeria and 21 more
- Volunteers
- 124 people
- Sponsor
- Novo Nordisk A/S
Infection, Human Immunodeficiency Virus, HIV Infections
Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects
This is a 48-week study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of an investigational regimen including FDA approved HIV drugs in HIV-infected pediatric subjects, ages 4 weeks to < 2 years…
- Trial name
- NCT00071760
- Testing
- GW433908, ritonavir
- Where
- 15 sites in United States, Argentina and 5 more
- Volunteers
- 59 people
- Sponsor
- ViiV Healthcare
Malaria, Falciparum
Chlorproguanil-Dapsone-Artesunate Versus COARTEM For Uncomplicated Malaria
Chlorproguanil-dapsone has been approved for the treatment of uncomplicated Plasmodium falciparum malaria in a number of countries across sub-Sahara Africa, and by the UK's Medicines and Healthcare products Regulatory Agency.
- Trial name
- NCT00344006
- Testing
- chlorproguanil-dapsone-artesunate, artemether-lumefantrine
- Where
- 9 sites in Burkina Faso, Ghana and 3 more
- Volunteers
- 1,395 people
- Sponsor
- GlaxoSmithKline
Allergic Rhinitis
Assess the Efficacy and Safety of Rhinocort Aqua
The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.
- Trial name
- NCT00641693
- Testing
- Budesonide
- Volunteers
- 650 people
- Sponsor
- AstraZeneca
Dermatitis, Atopic
Tacrolimus Ointment Long Term Safety in Young Children With Atopic Dermatitis
The objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis.
- Trial name
- NCT00560326
- Testing
- Tacrolimus Ointment 0.03%
- Where
- 8 sites in Canada, Finland and 3 more
- Volunteers
- 50 people
- Sponsor
- Astellas Pharma Inc