Status:
COMPLETED
Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers
Lead Sponsor:
Research Associates of New York, LLP
Conditions:
Gastroduodenal Ulcer
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Gastroduodenal ulcers are extremely common in the community today. Though much has been written and observed concerning how ulcers form, not much has been described in the human model concerning how t...
Detailed Description
In order to assess the extent of healing of the biopsy sites, a 12-point scale was developed and validated. After all of the procedures were complete, this scale was used to measure the effects of th...
Eligibility Criteria
Inclusion
- Signed informed consent
- Age 18-75
- Use of appropriate form of birth control for women of childbearing potential.
Exclusion
- H pylori infection
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00778193
Start Date
October 1 2007
End Date
March 1 2008
Last Update
October 23 2008
Active Locations (1)
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1
Research Associates of New York
New York, New York, United States, 10075