MedTrace Logo

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

NCT00778193 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2008-10-23

No results posted yet for this study

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.

Conditions

  • Gastroduodenal Ulcer

Interventions

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

Sponsors & Collaborators

  • Research Associates of New York, LLP

    lead OTHER

Principal Investigators

  • James Aisenberg, MD · Research Associates of New York

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-03-31
Completion
2008-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00778193 on ClinicalTrials.gov