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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Peptic Ulcer/Erosions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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pantoprazole

pantoprazole 20 mg om and matching placebo nocte

Group Type ACTIVE_COMPARATOR

pantoprazole vs famotidine

Intervention Type DRUG

pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte

famotidine

Famotidine 40 mg om and nocte

Group Type ACTIVE_COMPARATOR

pantoprazole vs famotidine

Intervention Type DRUG

pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte

Interventions

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pantoprazole vs famotidine

pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte

Intervention Type DRUG

Other Intervention Names

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pantoloc famotidine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No