drugset / Trial / NCT00787254

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

NCT00787254 ↗

Phase 3 Completed 366 enrolled Takeda
RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

Start
2007-04
Primary completion
2009-05
Completion
2009-05

Outcome

Met primary endpoint

registry p <0.0001; Hazard Ratio (HR) 0.2510 (95% CI 0.1400 to 0.4499); Log Rank NCT00787254 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gefarnate Small molecule 50 mg Oral
Subject Lansoprazole Other / unclassified 15 mg Oral