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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Eisai Co., Ltd.

Current Primary Outcome: Cumulative Recurrent Rates of Gastric or Duodenal Ulcers [ Time Frame: 24 weeks ]

Mucosal injuries with a white coat measuring 3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved.


Original Primary Outcome: Cumulative Recurrent Rates of Gastric or Duodenal Ulcers [ Time Frame: 24 weeks ]

Mucosal injuries with a white coat measuring ≥3 mm in diameter will be diagnosed as ulcers. When ulcer is confirmed by endoscopic examination during the trial, it will be regarded as recurrence of ulcer and the trial will be discontinued for the patient involved. Cumulative recurrent rates will be estimated by the Kaplan-Meier method, and their 95% confidence intervals will be calculated.


Current Secondary Outcome: Cumulative Incidence of Bleeding Ulcers [ Time Frame: 24 weeks ]

Original Secondary Outcome:

Information By: Eisai Inc.

Dates:
Date Received: July 18, 2011
Date Started: July 2011
Date Completion:
Last Updated: November 25, 2014
Last Verified: October 2014