Famotidine Compared With Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion

February 12, 2009 updated by: Ruttonjee Hospital

Famotidine vs. Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion - a Randomized Controlled Study

Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease, but its use is frequently limited by gastrointestinal side effects.

The position of H2-receptor antagonists as a step-down therapy after healing of peptic ulcer or erosions by proton pump inhibitor is unclear.

The objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Low-dose aspirin can prevent cerebral and cardiovascular accidents in individuals with symptomatic atherothrombotic disease . Its use is frequently limited by gastrointestinal side effects, ranging from dyspepsia (31%) to life-threatening bleeding or perforation of gastroduodenal ulcers (3.1%) over a period of 4 years .

The best approach for the secondary prevention of low-dose aspirin induced symptomatic peptic ulcer or erosions in patients who need to continue aspirin remain uncertain. At present, eradication of Helicobacter pylori infection and long-term maintenance with proton pump inhibitor PPI appears to be the best options.

The position of H2-receptor antagonists (H2RA) as a step-down therapy after healing of peptic ulcer or erosions is unclear.

The objective of this randomized, double blinded control study was to compare the efficacy of high-dose famotidine with pantoprazole in the prevention of recurrent dyspeptic or complicated ulcer/ erosions in patients taking low-dose aspirin.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 4

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

  • China
    • Hong Kong
      • Wan Chai, Hong Kong, China
        • Ruttonjee 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • upper GIB or dyspepsia due to peptic ulcers / erosions while receiving low-dose aspirin with a daily dose ranging from 80 mg to 320 mg
  • endoscopy revealed a gastric or duodenal ulcers of 3 mm or more in diameter with unequivocal depth, or more than 5 erosions in the stomach or duodenum
  • they required continuous low-dose aspirin for the secondary prevention of coronary heart disease, peripheral vascular disease and ischemic stroke or transient ischemic attacks
  • 18 years old or older.

Exclusion Criteria:

  • concurrent erosive or ulcerative esophagitis
  • pyloric stenosis
  • previous gastric or duodenal surgery other than oversewing of a perforation
  • thrombocytopenia
  • renal failure with estimated creatinine clearance less than 10 ml / min
  • active cancer
  • known allergic to aspirin, famotidine or pantoprazole
  • pregnancy, lactation, child-bearing potential in the absence of contraception
  • psychosomatic disorder
  • planned co-prescription of nonsteriodal anti-inflammatory drugs corticosteriod, or anticoagulant
  • disorders that might modify the absorption of study drugs

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pantoprazole
pantoprazole 20 mg om and matching placebo nocte
Drug: pantoprazole vs famotidine
pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte
Other Names:
  • pantoloc
  • famotidine
Active Comparator: famotidine
Famotidine 40 mg om and nocte
Drug: pantoprazole vs famotidine
pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte
Other Names:
  • pantoloc
  • famotidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions.
Time Frame: 48 weeks
48 weeks

Collaborators and Investigators

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

Sponsor

Ruttonjee Hospital

Investigators

  • Principal Investigator: Fook Hong Ng, M.D., Department of Medicine, Ruttonjee Hospital

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

August 1, 2004

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

February 12, 2009

First Submitted That Met QC Criteria

February 12, 2009

First Posted (Estimate)

February 13, 2009

Study Record Updates

Last Update Posted (Estimate)

February 13, 2009

Last Update Submitted That Met QC Criteria

February 12, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKEC 2004-016

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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