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-
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 472
- Primary Endpoint
- Cumulative Recurrent Rates of Gastric or Duodenal Ulcers
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
E3810 5 mg
Intervention: E3810 (Drug)
E3810 10 mg
Intervention: E3810 (Drug)
Teprenone 150 mg
Intervention: Teprenone (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Cumulative Incidence of Bleeding Ulcers(24 weeks)