CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 405 enrolled
Drug / intervention
Rabeprazole +1 moredrug
Likely dose
Rabeprazole 5 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/NCT01398410
NCT01398410Phase 3Completed

Long-term Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment. - A Multicenter, Randomized, Parallel-group, Open-label Trial-

Eisai Co., Ltd.·interventional·Posted Jul 20, 2011·Updated Dec 21, 2015

In Brief

A Phase 3 clinical trial evaluating Rabeprazole for Gastric Ulcers Duodenal Ulcers Caused by Low-dose Aspirin. Completed, enrolled 405 participants across 50 sites.

Detailed Summary

The primary objective of this study to examine the long-term safety of rabeprazole 5 mg or 10 mg tablets administered once daily in participants who were confirmed to have no recurrence of gastric or duodenal ulcer by endoscopic examination at the end of 24 weeks of treatment in the E3810-J081-308 (NCI01397448) \[Double-Blind Phase\] study. From a total of 420 participants who completed the E3810-J081-308 study, 328 entered the E3810-J081-309 (NCT01398410) study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 20, 2011
Enrollment StartDec 1, 2011
Primary CompletionDec 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 15.0 years ago

Interventions

Rabeprazoledrug

Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily

Rabeprazoledrug

Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily