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

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.

Timeline

Start

2007-05

Primary completion

2008-11

Completion

2008-11

Outcome

Met primary endpoint

Stopped: “AG-1749 superior to Gefarnate in ulcer prevention”

registry p <0.0001; Hazard Ratio (HR) 0.0989 (95% CI 0.0425 to 0.2300); Log Rank NCT00762359 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Gefarnate	Small molecule	50 mg	Oral
Subject	Lansoprazole	Other / unclassified	15 mg	Oral

Indications