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Completed

NCT Number: NCT02418312

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

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

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Key information

Conditions

Peptic Ulcer Digestive System Diseases Duodenal Diseases Gastrointestinal Diseases Intestinal Diseases Stomach Diseases

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, 813, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

histamine-2 receptor antagonist

Drug

famotidine 40 mg qd plus thienopyridine

Other names: famotidine 40 mg qd

Placebo

Drug

placebo plus thienopyridine

Primary outcomes

  1. Number of Participants With Healed Peptic Ulcer

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 16, 2015
Registry last updated
Mar 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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