Conditions: Gastric Ulcer Duodenal Ulcer Rheumatoid Arthritis Osteoarthritis Lumbago
Keywords: gastrointestinal GI NSAID Japan Japanese Gastric ulcer duodenal ulcer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 343
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the efficacy of esomeprazole (D961H) 20 mg versus placebo once daily for up to 24 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating presence or absence of gastric and/or duodenal ulcers throughout the treatment period (24 weeks) in terms of efficacy on prevention of gastric and/or duodenal ulcers

Detailed description:

Arms:
arm 1: Placebo arm 2: Esomeprazole 20 mg

Interventions: intervention 1: Esomeprazole intervention 2: Placebo
Intervention descriptions: intervention 1: 20mg once daily oral intervention 2: once daily oral

Protocol document: