drugset / Trial / NCT01398410

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

NCT01398410

Phase 2/3 Completed 405 enrolled Eisai Inc.
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2011-12
Primary completion
2013-12
Completion
2014-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Rabeprazole Small molecule 5 mg Oral
Subject Rabeprazole Small molecule 10 mg Oral