NCT00778193

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Research Associates of New York, LLP · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastroduodenal Ulcer

Interventions

Type	Name	Description
DRUG	Naproxen	1 tablet 500mg BID for 8 days
DRUG	Aspirin	1 tablet 81mg QD for 8 days
DRUG	Celecoxib	1 capsule 200mg QD for 8 days
DRUG	Clopidogrel	Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days
DRUG	Placebo	1 capsule BID for 8 days

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2008-10-23
• Last updated: 2008-10-23

Locations

1 site across 1 country: United States