Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer

Not Applicable

Completed

• Conditions: Peptic Ulcer
• Interventions: Drug: histamine-2 receptor antagonist; Drug: Placebo

• Registration Number: NCT02418312
• Lead Sponsor: Kaohsiung Veterans General Hospital.

Brief Summary

Whether H2 receptor antagonist can prevent thienopyridine-related peptic ulcer remains unclear.

Detailed Description

The aim of the prospective, randomized study is investigate the efficacy of H2 receptor antagonist in prevention of thienopyridine-related peptic ulcer and gastrointestinal bleeding in patients with an ulcer history. We plan to enroll 236 thienopyridine (clopidogrel or ticlopidine) users with a peptic ulcer history who don't have baseline gastroduodenal ulcers at initial endoscopy . The patients will be randomly assigned to receive either (1) famotidine (40 mg qd) plus thienopyridine used previously or (2) placebo plus thienopyridine treatment alone for 6 months. The ulcer recurrence rate between the treatment gruops will be compared.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2015-04-12
• Study First Submitted QC: 2015-04-15
• Study First Posted: 2015-04-16
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Results First Submitted: 2017-10-20
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-08
• Last Update Submitted: 2019-03-08
• Results First Posted: 2019-03-11
• Last Update Posted: 2019-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

1. The past history of gastroduodenal ulcer and underwent endoscopy for dyspeptic symptoms.
2. thienopyridine users without baseline gastroduodenal ulcer at initial endoscopy.
3. They are adult patients aged least 20 years of age.

Exclusion Criteria

1. They have a history of gastric or duodenal surgery other than oversewing of a perforation.
2. They require long-term treatment with non-steroidal anti-inflammatory drugs.
3. serious disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
histamine-2 receptor antagonist group	histamine-2 receptor antagonist	famotidine 40mg qd for 6 months.
placebo group	Placebo	placebo for 6 months.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan