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