A phase I/III study of D961H 10 mg and 20 mg in Japanese paediatric patients with gastrointestinal acid related diseases
Study identifier:D961TC00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open-label, parallel-group, multi-centre, phase I/III study to assess the safety, pharmacokinetics, pharmacodynamics and efficacy of repeated once-daily oral administration of D961H 10 mg and D961H 20 mg in Japanese paediatric patients 1 to 14 years old with gastrointestinal acid related diseases
Medical condition
Gastric ulcer (GU)
Phase
Phase 3
Healthy volunteers
No
Study drug
D961H sachet 10 mg, D961H capsule 10mg, D961H capsule 20 mg
Sex
All
Actual Enrollment
55
Study type
Interventional
Age
1 Years - 14 Years
Date
Study Start Date: 01 Jun 2014
Primary Completion Date: 01 Apr 2016
Study Completion Date: 01 Apr 2016
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1: D961H sachet 10 mg Age: ≥1 year Weight: <20 kg | - |
| Experimental: Group 2: D961H capsule 10mg Age: ≥1 year to 11years Weight: ≥20 kg | - |
| Experimental: Group 3: D961H capsule 20 mg Age: ≥1 year to 11years Weight: ≥20 kg | - |
| Experimental: Group 4: D961H capsule 10 mg Age: 12 to 14 years Weight: ≥20 kg | - |
| Experimental: Group 5: D961H capsule 20 mg Age: 12 to 14 years Weight: ≥20 kg | - |
