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

Kaohsiung Veterans General Hospital.101 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

101

Conditions

Peptic Ulcer

Interventions

histamine-2 receptor antagonist groupDRUG

famotidine tab 40 mg qd for 6 months.

proton pump inhibitor groupDRUG

pantoprazole tab 40 mg qd for 6 months.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Outcomes

Primary Outcomes

Number of Participants With Ulcer Recurrence

Follow-up endoscopy was performed at the end of the 6th month

Time frame: six month

Data from ClinicalTrials.gov

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