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

Kaohsiung Veterans General Hospital

Status: Completed

Conditions: Peptic Ulcer

Treatments: Drug: histamine-2 receptor antagonist group; Drug: proton pump inhibitor group

Study type: Interventional

Funder types: Other

Identifiers

NCT02551744

VGHKS12-CT7-08

Details and patient eligibility

About

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

Full description

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.

Enrollment: 101 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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101 participants in 2 patient groups

proton pump inhibitor group

Active Comparator group

Description:

Pantoprazole Tab 40mg qd for 6 monthrs.

Treatment:

Drug: proton pump inhibitor group

histamine-2 receptor antagonist group

Experimental group

Description:

famotidine Tab 40 mg qd for 6 months.

Treatment:

Drug: histamine-2 receptor antagonist group