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

Gastroduodenal Ulcer Clinical Trial

— Lesions2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00778193
• Other study ID #: Healing Study
• Secondary ID: GA319181
• Status: Completed
• Phase: Phase 4
• First received: July 24, 2008
• Last updated: October 22, 2008
• Start date: October 2007
• Est. completion date: March 2008

Study information

• Verified date: October 2008
• Source: Research Associates of New York, LLP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

N/A

Related Conditions & MeSH terms

• Gastroduodenal Ulcer
• Peptic Ulcer
• Ulcer

Intervention

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

Locations

Country	Name	City	State
United States	Research Associates of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Research Associates of New York, LLP

Country where clinical trial is conducted

United States, 

References & Publications (1)

Desai JC, Sanyal SM, Goo T, Benson AA, Bodian CA, Miller KM, Cohen LB, Aisenberg J. Primary prevention of adverse gastroduodenal effects from short-term use of non-steroidal anti-inflammatory drugs by omeprazole 20 mg in healthy subjects: a randomized, double-blind, placebo-controlled study. Dig Dis Sci. 2008 Aug;53(8):2059-65. doi: 10.1007/s10620-007-0127-4. Epub 2008 Jan 26. — View Citation