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Completed

NCT Number: NCT00843063

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

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pantoprazole vs famotidine

Drug

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

Other names: pantoloc, famotidine

Primary outcomes

  1. The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions.

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Ruttonjee Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Feb 13, 2009
Registry last updated
Feb 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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