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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 the study drugs on the healing of the biopsy-induced ulcers.

Official Title
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A Randomized, Blinded, Placebo-Controlled Study of the Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on Gastroduodenal Healing

Conditions
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Gastroduodenal Ulcer

Intervention / Treatment
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* Drug: Naproxen
* Drug: Aspirin
* Drug: Celecoxib
* Drug: Clopidogrel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Age 18-75 Use of appropriate form of birth control for women of childbearing potential. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 capsule BID for 8 days<br>* Other names: sugar pill;|
| Active Comparator: Naproxen<br> | Drug: Naproxen<br>* 1 tablet 500mg BID for 8 days<br>* Other names: Synflex;|
| Experimental: Aspirin<br> | Drug: Aspirin<br>* 1 tablet 81mg QD for 8 days<br>* Other names: Bayer;|
| Experimental: Clopidogrel<br> | Drug: Clopidogrel<br>* Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days<br>* Other names: Plavix;|
| Experimental: Celecoxib<br> | Drug: Celecoxib<br>* 1 capsule 200mg QD for 8 days<br>* Other names: Celebrex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSAID, ulcer, gastroduodenal ulcer, naproxen, aspirin, ASA, celecoxib, clopidogrel, healing, Cyclooxygenase 2 Inhibitors, Anti-Inflammatory Agents, Non-Steroidal, Platelet Aggregation Inhibitors, Wound Healing