Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers (Lesions2)

Research Associates of New York, LLP

Status and phase

Completed

Phase 4

Conditions

Gastroduodenal Ulcer

Treatments

Drug: Celecoxib

Drug: Placebo

Drug: Naproxen

Drug: Clopidogrel

Drug: Aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT00778193

Healing Study

GA319181

Details and patient eligibility

About

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.

Full 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.

Enrollment

125 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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.