CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 472 enrolled
Drug / intervention
E3810 +2 moredrug
Likely dose
E3810 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/NCT01397448
NCT01397448Phase 3Completed
CompareCT.gov

Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment. - A Multicenter, Randomized, Parallel-group, Double-blind Comparative Trial-

Eisai Co., Ltd.·interventional·Posted Jul 19, 2011·Updated Nov 26, 2014

In Brief

A Phase 3 clinical trial evaluating E3810 and Teprenone for Gastric or Duodenal Ulcers Caused by Low-dose Aspirin. Completed, enrolled 472 participants across 49 sites.

Detailed Summary

The primary objective of this study to evaluate the effect of preventing recurrence of gastric or duodenal ulcers by administering E3810 5 mg or 10 mg tablets once daily or Teprenone 150 mg/day (50 mg three times daily) as a control to patients receiving low-dose aspirin and thereby examine the superiority of E3810 over Teprenone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGastric or Duodenal Ulcers Caused by Low-dose Aspirin
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 19, 2011
Enrollment StartJul 1, 2011
Primary CompletionMar 1, 2013
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 15.0 years ago

Interventions

E3810drug

E3810 5 mg/day Group: Orally administered E3810 5 mg tablets and E3810 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal.

E3810drug

E3810 10 mg Group: Orally administered E3810 5 mg placebo tablets and 10 mg tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal.

Teprenonedrug

Teprenone 150 mg/day Group: Orally administered E3810 5 mg placebo tablets and 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg capsules three times daily after each meal.