Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers
NCT ID: NCT00778193
Last Updated: 2008-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
125 participants
INTERVENTIONAL
2007-10-31
2008-03-31
Brief Summary
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Detailed Description
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After all of the procedures were complete, this scale was used to measure the effects of the study drugs on the healing of the biopsy-induced ulcers.
Conditions
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Keywords
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Study Groups
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Placebo
Placebo
1 capsule BID for 8 days
Naproxen
Naproxen
1 tablet 500mg BID for 8 days
Aspirin
Aspirin
1 tablet 81mg QD for 8 days
Clopidogrel
Clopidogrel
Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days
Celecoxib
Celecoxib
1 capsule 200mg QD for 8 days
Interventions
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Naproxen
1 tablet 500mg BID for 8 days
Aspirin
1 tablet 81mg QD for 8 days
Celecoxib
1 capsule 200mg QD for 8 days
Clopidogrel
Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days
Placebo
1 capsule BID for 8 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 18-75
* Use of appropriate form of birth control for women of childbearing potential.
Exclusion Criteria
* Use of NSAIDs within 2 weeks prior to start of enrollment
* Use of antacids or H-2 blockers within 2 weeks of enrollment
* Use of PPIs within 30 days of enrollment
* Corticosteroid use within 60 days of enrollment
* History of a previous ulcer
* Diagnosis of a bleeding diathesis or use of warfarin within 60 days of enrollment
* Use of cigarettes within 6 months of enrollment
* Consumption of \>3 alcoholic beverages per day
* Hypersensitivity or allergy to NSAIDs, clopidogrel, or corn starch, or any contraindications to ingesting those substances
* The presence of an ulcer at a baseline endoscopy
* Endoscopically severe gastritis or duodenitis baseline endoscopy
* Moderate or severe inflammation located within the duodenal bulb or within 2cm of the pyloric channel at a baseline endoscopy
* Any gastroduodenal tumor.
18 Years
75 Years
ALL
Yes
Sponsors
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Research Associates of New York, LLP
OTHER
Responsible Party
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Research Associates of New York
Principal Investigators
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James Aisenberg, MD
Role: PRINCIPAL_INVESTIGATOR
Research Associates of New York
Locations
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Research Associates of New York
New York, New York, United States
Countries
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References
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Desai JC, Sanyal SM, Goo T, Benson AA, Bodian CA, Miller KM, Cohen LB, Aisenberg J. Primary prevention of adverse gastroduodenal effects from short-term use of non-steroidal anti-inflammatory drugs by omeprazole 20 mg in healthy subjects: a randomized, double-blind, placebo-controlled study. Dig Dis Sci. 2008 Aug;53(8):2059-65. doi: 10.1007/s10620-007-0127-4. Epub 2008 Jan 26.
Other Identifiers
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GA319181
Identifier Type: -
Identifier Source: secondary_id
Healing Study
Identifier Type: -
Identifier Source: org_study_id