Proton Pump Inhibitor Versus Histamine-2 Receptor Antagonist for the Prevention of Recurrent Peptic Ulcers

Study Overview
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Brief Summary
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Whether pantoprazole versus famotidine for the prevention of recurrent peptic ulcers in thienopyridine users remains unclear.

Detailed Description
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The aims of the randomized double-blind comparison study are to compare the efficacy of Proton Pump Inhibitor and H2 receptor antagonist for the prevention of recurrent peptic ulcers in thienopyridine users. We plan to enroll 334 thienopyridine (clopidogrel or ticlopidine) users without baseline gastroduodenal ulcer at initial endoscopy. The patients will be randomly assigned to receive either (1) pantoprazole (40 mg qd) or (2) famotidine (40 mg qd) for 6 months.The ulcer recurrence rate between the treatment groups will be compared.

Official Title
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Pantoprazole Versus Famotidine for the Prevention of Recurrent Peptic Ulcers in Thienopyridine Users - a Double-blind Randomized Controlled Trial

Conditions
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Peptic Ulcer

Intervention / Treatment
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* Drug: histamine-2 receptor antagonist group
* Drug: proton pump inhibitor group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recent endoscopic examination (within 2 months) reveals normal appearance or erythematous patches only (without subepithelial hemorrhages, erosions or ulcers). Peptic ulcers (a mucosal break ³ 5 mm in diameter) have been documented by a previous endoscopic examination. Subjects have received thienopyridine therapy for at least two weeks. Requiring long-term anti-platelet therapy for ischemic cardiovascular diseases. Exclusion Criteria: A history of gastric or duodenal surgery other than oversewing of a perforation. Subjects who are allergic to the study drugs. Requiring long-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, aspirin, or anticoagulant agents. Pregnancy. Subjects who have active cancer, acute serious medical illness or terminal illness. Subjects who have gastroesophageal reflux disease.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: proton pump inhibitor group<br>Pantoprazole Tab 40mg qd for 6 monthrs. | Drug: proton pump inhibitor group<br>* pantoprazole tab 40 mg qd for 6 months.<br>* Other names: pantoprazole 40mg;|
| Experimental: histamine-2 receptor antagonist group<br>famotidine Tab 40 mg qd for 6 months. | Drug: histamine-2 receptor antagonist group<br>* famotidine tab 40 mg qd for 6 months.<br>* Other names: famotidine 40 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Ulcer Recurrence | Follow-up endoscopy was performed at the end of the 6th month | six month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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histamine-2 receptor antagonist, proton pump inhibitor, thienopyridine, clopidogrel, prevention