Overview

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

Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ruttonjee Hospital
Treatments:
Aspirin
Famotidine
Pantoprazole
Criteria
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