A Comparison of Two Therapeutic Strategies for the Treatment of Aspirin-associated Peptic Ulcers

Overview

Esomeprazole plus aspirin compared with esomeprazole alone for the treatment of aspirin-related peptic ulcers.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2008

Detailed Description

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.

Interventions

  • 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

Primary 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

Secondary Measures

  • 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

Inclusion Criteria

  • 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

Investigator Details

  • 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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