Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers (Lesions2)
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.
|Official Title:||A Randomized, Blinded, Placebo-Controlled Study of the Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on Gastroduodenal Healing|
|Study Start Date:||October 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Placebo||
1 capsule BID for 8 days
Other Name: sugar pill
|Active Comparator: Naproxen||
1 tablet 500mg BID for 8 days
1 tablet 81mg QD for 8 days
Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days
Other Name: Plavix
1 capsule 200mg QD for 8 days
Other Name: Celebrex
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.
|United States, New York|
|Research Associates of New York|
|New York, New York, United States, 10075|
|Principal Investigator:||James Aisenberg, MD||Research Associates of New York|