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

NCT00843063 | Completed Phase 4 DMC

• 1 other identifier: HKEC 2004-016
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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

Conditions

Peptic Ulcer/Erosions

Keywords

pantoprazole; famotidine; aspirin; dyspepsia; gastrointestinal bleeding; peptic ulcer / erosion

Outcome Measures

Primary Outcomes (1)

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

  48 weeks

Study Arms (2)

pantoprazole

ACTIVE COMPARATOR

pantoprazole 20 mg om and matching placebo nocte

Drug: pantoprazole vs famotidine

famotidine

ACTIVE COMPARATOR

Famotidine 40 mg om and nocte

Drug: pantoprazole vs famotidine

Interventions

pantoprazole vs famotidine DRUG

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

Also known as: pantoloc, famotidine

famotidine; pantoprazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years old or older.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruttonjee Hospital: lead

Study Sites (1)

Ruttonjee Hospital

Wan Chai, Hong Kong, China

Location

MeSH Terms

Conditions

Peptic Ulcer; Dyspepsia; Gastrointestinal Hemorrhage

Interventions

Famotidine

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hemorrhage; Pathologic Processes

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fook Hong Ng, M.D.

  Department of Medicine, Ruttonjee Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: August 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 13, 2009

Record last verified: 2009-02

Locations

CN (1)