NCT00595517

Long Term Study to Investigate the Efficacy & Safety of D961H (Esomeprazole) for the Prevention of NSAIDs-induced Ulcer

A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg Once Daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated With Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the Safety and tolerability of D961H (Esomeprazole) 20 mg once daily for up to 52 weeks of treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily nonsteroidal anti-inflammatory drug (NSAID) therapy by evaluating AE, clinical laboratory value and vital signs.

Conditions

• Gastric Ulcer
• Duodenal Ulcer
• Rheumatoid Arthritis
• Osteoarthritis
• Lumbago

Interventions

Type	Name	Description
DRUG	Esomeprazole 20 mg	Esomeprazole 20 mg once daily

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-01-16
• Last updated: 2012-09-14
• Results posted: 2012-09-14

Locations

3 sites across 1 country: Japan