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NCT01353144 Clinical Trial

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

Peptic Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01353144
Other study ID # VGHKS96-CT4-26
Secondary ID
Status Completed
Phase Phase 4
First received May 11, 2011
Last updated September 14, 2015
Start date June 2007
Est. completion date May 2008

Study information
Verified date September 2015
Source Kaohsiung Veterans General Hospital.
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 232
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• aspirin
aspirin, 100 mg, qd x 8 weeks

Locations
Country Name City State
Taiwan Chung-Ho Hospital Kaohsiung
Taiwan Kaohsiung Veterans General Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Kaohsiung Veterans General Hospital.

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of Ulcer Healing ulcer healing rate at week 8 8 weeks No
Secondary Rate of Peptic Ulcer Bleeding rate of peptic ulcer bleeding within 8-week study period 8 weeks No
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