Gastroduodenal Ulcer
Conditions
Keywords
NSAID, ulcer, gastroduodenal ulcer, naproxen, aspirin, ASA, celecoxib, clopidogrel, healing, Cyclooxygenase 2 Inhibitors, Anti-Inflammatory Agents, Non-Steroidal, Platelet Aggregation Inhibitors, Wound Healing
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 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
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.
Interventions
DRUGNaproxen
1 tablet 500mg BID for 8 days
DRUGAspirin
1 tablet 81mg QD for 8 days
DRUGCelecoxib
1 capsule 200mg QD for 8 days
DRUGClopidogrel
Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days
DRUGPlacebo
1 capsule BID for 8 days
Sponsors
Research Associates of New York, LLP
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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.
Countries
United States
Outcome results
None listed