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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

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220521
Enrollment
Unknown
Registered
2008-02-21
Start date
2008-02-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Ulcer, Duodenal Ulcer, Rheumatoid Arthritis, Osteoarthritis, Lumbago

Interventions

investigational material(s) Generic name etc : esomeprazole INN of investigational material : Therapeutic category code : 232 Agents for peptic ulcer Dosage and Administration for Investigational mat

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026