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

This study has been completed.
Sponsor:
Information provided by:
Ruttonjee Hospital
ClinicalTrials.gov Identifier:
NCT00843063
First received: February 12, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Peptic Ulcer/Erosions
Drug: pantoprazole vs famotidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Famotidine vs. Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion - a Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Ruttonjee Hospital:

Primary Outcome Measures:
  • The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions. [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 161
Study Start Date: August 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: pantoprazole
pantoprazole 20 mg om and matching placebo nocte
Drug: pantoprazole vs famotidine
pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte
Other Names:
  • pantoloc
  • famotidine
Active Comparator: famotidine
Famotidine 40 mg om and nocte
Drug: pantoprazole vs famotidine
pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte
Other Names:
  • pantoloc
  • famotidine

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00843063

Locations
China, Hong Kong
Ruttonjee Hospital
Wan Chai, Hong Kong, China
Sponsors and Collaborators
Ruttonjee Hospital
Investigators
Principal Investigator: Fook Hong Ng, M.D. Department of Medicine, Ruttonjee Hospital
  More Information

No publications provided

Responsible Party: Dr Fook Hong Ng, Ruttonjee Hospital
ClinicalTrials.gov Identifier: NCT00843063     History of Changes
Other Study ID Numbers: HKEC 2004-016
Study First Received: February 12, 2009
Last Updated: February 12, 2009
Health Authority: Hong Kong: Ethics Committee

Keywords provided by Ruttonjee Hospital:
pantoprazole
famotidine
aspirin
dyspepsia
gastrointestinal bleeding
peptic ulcer / erosion

Additional relevant MeSH terms:
Peptic Ulcer
Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Aspirin
Pantoprazole
Famotidine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics

ClinicalTrials.gov processed this record on July 26, 2014