Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers

Completed · Phase 4 · Has a placebo group

Conditions studied: Gastroduodenal Ulcer

In brief

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 these ulcers heal. As numerous patients already suffer from gastrointestinal ulcers, further clarification of ulcer healing would be valuable in the treatment and management of these patients. The goal of this study is to investigate the effects of naproxen, aspirin, celecoxib, and clopidogrel on biopsy-induced gastroduodenal lesions in order to elucidate the mechanisms of ulcer healing. This single site, single-blind, randomized, placebo-controlled, one-week prospective study will examine ulcer healing through endoscopic, immunohistologic, and molecular PCR modalities.

Key facts

Study ID

NCT00778193

Run by

Research Associates of New York, LLP

People needed

125

Starts

2007-10-01

Expected to finish

2008-03-01

Last updated by the study team

2008-10-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Signed informed consent
• Age 18-75
• Use of appropriate form of birth control for women of childbearing potential.

You may not qualify if…

• 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.

Where it is running

• Research Associates of New York — New York, New York, United States

Full record on ClinicalTrials.gov

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