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

Primary Purpose

Peptic Ulcer/Erosions

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
pantoprazole vs famotidine
Sponsored by
Ruttonjee Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peptic Ulcer/Erosions focused on measuring pantoprazole, famotidine, aspirin, dyspepsia, gastrointestinal bleeding, peptic ulcer / erosion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ruttonjee Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

pantoprazole

famotidine

Arm Description

pantoprazole 20 mg om and matching placebo nocte

Famotidine 40 mg om and nocte

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 12, 2009
Last Updated
February 12, 2009
Sponsor
Ruttonjee Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00843063
Brief Title
Famotidine Compared With Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion
Official Title
Famotidine vs. Pantoprazole to Prevent Recurrent Aspirin-Induced Peptic Ulcer/Erosion - a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ruttonjee Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer/Erosions
Keywords
pantoprazole, famotidine, aspirin, dyspepsia, gastrointestinal bleeding, peptic ulcer / erosion

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
pantoprazole
Arm Type
Active Comparator
Arm Description
pantoprazole 20 mg om and matching placebo nocte
Arm Title
famotidine
Arm Type
Active Comparator
Arm Description
Famotidine 40 mg om and nocte
Intervention Type
Drug
Intervention Name(s)
pantoprazole vs famotidine
Other Intervention Name(s)
pantoloc, famotidine
Intervention Description
pantoprazole 20 mg om and matching placebo nocte vs. famotidine 40 mg om and nocte
Primary Outcome Measure Information:
Title
The primary end-point was the recurrence of dyspeptic or complicated ulcer / erosions.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fook Hong Ng, M.D.
Organizational Affiliation
Department of Medicine, Ruttonjee Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruttonjee Hospital
City
Wan Chai
State/Province
Hong Kong
Country
China

12. IPD Sharing Statement

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

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