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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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

Detailed Summary:

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.

Sponsor: Ruttonjee Hospital

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Ruttonjee Hospital

Dates:
Date Received: February 12, 2009
Date Started: August 2004
Date Completion:
Last Updated: February 12, 2009
Last Verified: February 2009