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Completed

NCT Number: NCT02551744

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

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

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Key information

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 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

histamine-2 receptor antagonist group

Drug

famotidine tab 40 mg qd for 6 months.

Other names: famotidine 40 mg

proton pump inhibitor group

Drug

pantoprazole tab 40 mg qd for 6 months.

Other names: pantoprazole 40mg

Primary outcomes

  1. Number of Participants With Ulcer Recurrence

    Time frame: six month

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

Sponsors and collaborators

Lead sponsor

Kaohsiung Veterans General Hospital.

Other

Registry information

Official study title

Pantoprazole Versus Famotidine for the Prevention of Recurrent Peptic Ulcers in Thienopyridine Users - a Double-blind Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2015
Registry last updated
Aug 8, 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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