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

Phase 4

Completed

• Conditions: Gastroduodenal Ulcer
• Interventions: Drug: Placebo; Drug: Naproxen; Drug: Aspirin; Drug: Clopidogrel; Drug: Celecoxib

• Registration Number: NCT00778193
• Lead Sponsor: Research Associates of New York, LLP

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.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Study First Submitted: 2008-07-24
• Status Verified: 2008-10
• Study First Submitted QC: 2008-10-22
• Last Update Submitted: 2008-10-22
• Study First Posted: 2008-10-23
• Last Update Posted: 2008-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Naproxen	Naproxen	-
Aspirin	Aspirin	-
Clopidogrel	Clopidogrel	-
Celecoxib	Celecoxib	-

Trial Locations

Locations (1)

Research Associates of New York; 🇺🇸 New York, New York, United States