drugset / Trial / NCT01397448

Prevention of Recurrent Gastric or Duodenal Ulcers Caused by Low-dose Aspirin With Rabeprazole (E3810) Treatment (Planetarium Study)

NCT01397448

Phase 2/3 Completed 472 enrolled Eisai Inc.
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2011-07
Primary completion
2013-03
Completion
2013-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Rabeprazole Small molecule 5 mg Oral
Subject Rabeprazole Small molecule 10 mg Oral
Comparator Teprenone Unknown 50 mg Oral