A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers

• Status: Terminated
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether lansoprazole, once daily (QD), compared to gefarnate, twice daily (BID), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with low dosage aspirin.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Aspirin; Dexlansoprazole; Gefarnate; Lansoprazole

Criteria

Inclusion Criteria:

• The patient was on low-dose aspirin treatment on the day when consent was obtained, and requires the long-term continuous treatment even after treatment with the investigational drug is started.

• The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

Exclusion Criteria:

• Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.

• Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.

• Current or past history of aspirin-induced asthma or hypersensitivity to nonsteroidal anti-inflammatory drugs.

• Past or planned surgery affecting gastric acid secretion.

• Clinically significant hepatic or renal disorder.