A Phase III, Multicentre, Randomised, Double-Blind, Parallel-Group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-Inflammatory Drug (NSAID) Use
Phase 3
- Conditions
- Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago
- Registration Number
- JPRN-jRCT2080220521
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Ages Eligible for Study: 20 Years and above
Genders Eligible for Study: Both
Inclusion Criteria:
- Medical history of gastric and/or duodenal ulcer
- A diagnosis of a chronic condition (rheumatoid arthritis, osteoarthritis, lumbago,etc) that requires daily NSAID use,at least 20 years of age
Exclusion Criteria
- Having gastric or duodenal ulcer in active or healing stage according to the Sakita/Miwa classification
- History of esophageal, gastric or duodenal surgery
- Having severe liver disease or chronic renal disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety/Efficacy Primary Outcome Measures: - Presence or absence of gastric and/or duodenal ulcer throughout the treatment period (24 weeks) Secondary Outcome Measures: - Presence or absence of gastric and/or duodenal ulcers for up to 4 weeks and 12 weeks after initial administration, Severity of gastric mucosal lesion, Presence/absence and severity of NSAID-induced gastrointestinal symptoms, AEs, lab values, vital signs
- Secondary Outcome Measures
Name Time Method