An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients With Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated With Non-steroidal Anti-inflammatory Drugs or Low-dose Aspiri
- Conditions
- Reflux Esophagitis, Gastric Ulcer, Duodenal Ulcer
- Registration Number
- JPRN-jRCT2080223965
- Lead Sponsor
- AstraZeneca KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 60
For healed reflux esophagitis study
-Endoscopically verified reflux esophagitis, Grade A or higher according to the Los Angels classification as judged by central evaluation committee
For prevention of gastric ulcer or duodenal ulcer recurrence study
-Patients with documented medical history of gastric ulser or duodenal ulser diagnosis based on upper gastrointestinal symptoms, fecal occult blood, esophagogastroduodenoscopy findings, etc
- Patients less than 10 kg in weight
- Use of any other investigational compounds or participations in another clinical trial within 4 weeks prior to the enrolment
- Significant clinical illness within 4 weeks prior to the informed consent
- Previous total gastrectomy
- Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by investigators. etc
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>-
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacodynamics<br>-