NCT01069939

Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin

A Phase III Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Efficacy and Safety Study of D961H (20 mg Once Daily) Versus Placebo for Prevention of Gastric and/or Duodenal Ulcers Associated With Continuous Low-dose Aspirin (LDA) Use

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 427 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers.

Conditions

• Prevention

Interventions

Type	Name	Description
DRUG	Esomeprazole	20mg, capsule, 72 weeks
DRUG	Placebo	Placebo, capsule, 72 weeks

Timeline

• Start date: 2010-02-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2010-02-17
• Last updated: 2012-11-22
• Results posted: 2012-11-22

Locations

46 sites across 3 countries: Japan, South Korea, Taiwan