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NCT01138969 Clinical Trial

Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer

Peptic Ulcer Clinical Trial

Official title:
Efficacy of Proton Pump Inhibitor in Prevention of Clopidogrel-related Peptic Ulcer and Gastrointestinal Bleeding

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01138969
Other study ID # VGHKS98-CT6-12
Secondary ID
Status Completed
Phase Phase 2
First received June 7, 2010
Last updated September 6, 2015
Start date August 2008
Est. completion date December 2012

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

Proton Pump Inhibitors (PPI) can prevent the recurrence of peptic ulcer in clopidogrel users.

Description:

The aim of the prospective, randomized study is to investigate the efficacy of PPI in prevention of ulcer recurrence for clopidogrel users. We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months. The ulcer recurrence rate between the treatment groups will be compared.

Recruitment information / eligibility
Status Completed
Enrollment 165
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- We plan to enroll 300 clopidogrel users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) esomeprazole (20 mg qd) plus clopidogrel or (2) clopidogrel treatment alone for 6 months.

Exclusion Criteria:

- 1.serious disease 2.refuse informed consent

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• esomeprazole
esomeprazole 20 mg qd for 6 months

Locations
Country Name City State
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 Recurrent Peptic Ulcer Number of participants with recurrent peptic ulcer within 6 months 6 months No
Secondary Peptic Ulcer Bleeding participants with peptic ulcer bleeding within 6 months 6 months No
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