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

Phase 4

Completed

• Conditions: Peptic Ulcer/Erosions
• Interventions: Drug: pantoprazole vs famotidine

• Registration Number: NCT00843063
• Lead Sponsor: Ruttonjee Hospital

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 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 Timeline

• Study Start: 2004-08
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-02
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Last Update Submitted: 2009-02-12
• Study First Posted: 2009-02-13
• Last Update Posted: 2009-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pantoprazole	pantoprazole vs famotidine	pantoprazole 20 mg om and matching placebo nocte
famotidine	pantoprazole vs famotidine	Famotidine 40 mg om and nocte

Primary Outcome Measures

Name	Time	Method
The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions.	48 weeks

Trial Locations

Locations (1)

Ruttonjee Hospital; 🇨🇳 Wan Chai, Hong Kong, China