Trials / Completed
CompletedNCT02153398
A Phase I/III Study of D961H 10 mg and 20 mg in Japanese Paediatric Patients With Gastrointestinal Acid Related Diseases
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 55 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 1 Year – 14 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is 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 aged 1 to 14 years old who either have a diagnosis of or are suspected to have gastric ulcer (GU), duodenal ulcer (DU), anastomotic ulcer (AU), non-erosive reflux esophagitis disease (NERD), reflux esophagitis (RE) or Zollinger-Ellison syndrome.
Conditions
- Gastric Ulcer (GU)
- Duodenal Ulcer (DU)
- Anastomotic Ulcer (AU)
- Non-erosive Reflux Esophagitis Disease (NERD)
- Reflux Esophagitis (RE)
- Zollinger-Ellison Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | D961H sachet 10 mg | |
| DRUG | D961H capsule 10mg | |
| DRUG | D961H capsule 20 mg |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2016-04-01
- Completion
- 2016-04-01
- First posted
- 2014-06-03
- Last updated
- 2017-01-19
- Results posted
- 2017-01-19
Locations
15 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02153398. Inclusion in this directory is not an endorsement.