An Open-label, Parallel-group, Multi-centre, Phase 1/3 Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of Repeated Once-daily Oral Administration of D961H 10mg and D961H 20mg in Japanese Paediatric Patients 1 to 14 Years Old With Gastrointestinal Acid Related Diseases
Phase 3
- Conditions
- Gastric Ulcer(GU), Duodenal Ulcer(DU), Anastomotic Ulcer(AU), Non-erosive Reflux Esophagitis Disease(NERD), Reflux Esophagitis(RE), Zollinger-Ellison Syndrome
- Registration Number
- JPRN-jRCT2080222552
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Provision of signed written informed consent from the patient's guardian.
-Patients aged 1 year or more to 14 years old.
-Patients who have a diagnosis of or suspected to have GU, DU, AU, NERD, RE or Zollinger-Ellison syndrome.
Exclusion Criteria
-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 randomisation/registration.
-Significant clinical illness within 4 weeks prior to the registration.
-Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by the investigators.
-Positive for pregnancy test by urinary or lactation for post-menarchal females.
-Previous total gastrectomy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method