NCT00787254

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

A Study to Investigate the Preventive Effect of AG-1749 Against the Recurrence of Gastric and Duodenal Ulcers During Long-term Treatment With Nonsteroid Anti-inflammatory Drug

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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).

Detailed description

In Japan, nonsteroid anti-inflammatory drug is one of common prescribed drugs for patients as an analgesic antipyretic, treating symptoms of cold, antiphlogistic and management of pain with rheumatoid arthritis, osteoarthrosis, lumbago. On the other hand, this nonsteroid anti-inflammatory drug sometimes causes gastric and duodenal ulcers and this ulcer leads to the gastrointestinal bleeding which may be cause of death. The purpose of this study is to assess the efficacy of lansoprazole versus gefarnate in patients with a history of gastric or duodenal ulcers receiving daily nonsteroid anti-inflammatory medication.

Conditions

• Stomach Ulcer
• Duodenal Ulcer

Interventions

Type	Name	Description
DRUG	Lansoprazole	Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.
DRUG	Gefarnate	Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2008-11-07
• Last updated: 2012-02-03
• Results posted: 2011-05-10

Locations

68 sites across 1 country: Japan