Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice daily (BID).

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

Details

• Lead Sponsor: Takeda
• Treatments: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Dexlansoprazole; Gefarnate; Lansoprazole

Criteria

Inclusion Criteria:

• The patient was on nonsteroid anti-inflammatory drug (NSAID) 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 NSAIDs.

• Past or planned surgery affecting gastric acid secretion.

• Clinically significant hepatic or renal disorder.

• Serious cardiac dysfunction, hypertension, or hematological disorder.