Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: May 2008
The aims of this study are to compare esomeprazole plus aspirin with esomeprazole alone in the treatment of aspirin-related ulcers. Patients with aspirin-related peptic ulcers are randomized to receive esomeprazole (40 mg/day) plus aspirin (100 mg/day) or esomeprazole (40 mg/day) alone for 8 weeks. Follow-up endoscopy was carried out at the end of the eighth week. The primary end point was the healing of peptic ulcers.
- Drug: aspirin
- aspirin, 100 mg, qd x 8 weeks
Arms, Groups and Cohorts
- No Intervention: esomeprazole
- esomeprazole (40 mg/day) for 8 weeks
- Active Comparator: esomeprazole plus aspirin
- esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks
Clinical Trial Outcome Measures
- Number of Participants in Whom Peptic Ulcer Was Healed
- Time Frame: 8 weeks
- Number of participants in whom peptic ulcer was healed at week 8
- Number of Participants Deveoping Peptic Ulcer Bleeding
- Time Frame: 8 weeks
- Number of participants deveoping peptic ulcer bleeding during 8-week study period
Participating in This Clinical Trial
- aspirin users who have a peptic ulcer confirmed by endoscopy Exclusion Criteria:
- serious medical illness (including cardiovascular events within 6 months before endoscopy) – acute gastrointestinal bleeding – a history of gastric or duodenal surgery – allergic to the study drugs – require long-term treatment with non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet agents, or anticoagulant agents – pregnancy
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Kaohsiung Veterans General Hospital.
- Provider of Information About this Clinical Study
- Principal Investigator: Ping-I (William) Hsu, M.D., Professor – Kaohsiung Veterans General Hospital.
- Overall Official(s)
- Kwok-Hung Lai, MD, Study Chair, Kaohsiung Veterans General Hospital.
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