CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 366 enrolled
Drug / intervention
Lansoprazole +1 moredrug
Likely dose
Lansoprazole 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00787254
NCT00787254Phase 3Completed
CompareCT.gov

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

Takeda·interventional·Posted Nov 7, 2008·Updated Feb 3, 2012

In Brief

A Phase 3 clinical trial evaluating Lansoprazole and Gefarnate for Stomach Ulcer and Duodenal Ulcer. Completed, enrolled 366 participants across 68 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStomach Ulcer, Duodenal Ulcer
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 7, 2008
Enrollment StartApr 1, 2007
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.7 years ago

Interventions

Lansoprazoledrug

Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.

Gefarnatedrug

Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.