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

Not Applicable

Completed

• Conditions: Peptic Ulcer
• Interventions: Drug: histamine-2 receptor antagonist group; Drug: proton pump inhibitor group

• Registration Number: NCT02551744
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2015-09-14
• Study First Submitted QC: 2015-09-15
• Study First Posted: 2015-09-16
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Results First Submitted: 2018-10-30
• Status Verified: 2019-06
• Results First Submitted QC: 2019-06-24
• Last Update Submitted: 2019-06-24
• Results First Posted: 2019-08-08
• Last Update Posted: 2019-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
histamine-2 receptor antagonist group	histamine-2 receptor antagonist group	famotidine Tab 40 mg qd for 6 months.
proton pump inhibitor group	proton pump inhibitor group	Pantoprazole Tab 40mg qd for 6 monthrs.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Ulcer Recurrence	six month	Follow-up endoscopy was performed at the end of the 6th month

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan