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

March 8, 2019 updated by: Ping-I (William) Hsu, M.D., Kaohsiung Veterans General Hospital.
Whether H2 receptor antagonist can prevent thienopyridine-related peptic ulcer remains unclear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

228

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 813
        • Kaohsiung Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: histamine-2 receptor antagonist group
famotidine 40mg qd for 6 months.
Drug: histamine-2 receptor antagonist
famotidine 40 mg qd plus thienopyridine
Other Names:
  • famotidine 40 mg qd
PLACEBO_COMPARATOR: placebo group
placebo for 6 months.
Drug: Placebo
placebo plus thienopyridine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Healed Peptic Ulcer
Time Frame: 6 months
Follow-up endoscopy was performed at the end of the 6th month
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Veterans General Hospital.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

April 12, 2015

First Submitted That Met QC Criteria

April 15, 2015

First Posted (ESTIMATE)

April 16, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2019

Last Update Submitted That Met QC Criteria

March 8, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VGHKS11-CT12-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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