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

October 22, 2008 updated by: Research Associates of New York, LLP

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

125

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10075
        • Research Associates of New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
1 capsule BID for 8 days
Other Names:
  • sugar pill
Experimental: Aspirin
Drug: Aspirin
1 tablet 81mg QD for 8 days
Other Names:
  • ASA
  • Bayer
Active Comparator: Naproxen
Drug: Naproxen
1 tablet 500mg BID for 8 days
Other Names:
  • Aleve
  • Anaprox
  • Naprelan
  • Naprogesic
  • Proxen
  • Synflex
  • naprosyn
  • naproxen sodium
  • Miranax
Experimental: Clopidogrel
Drug: Clopidogrel
Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days
Other Names:
  • Plavix
Experimental: Celecoxib
Drug: Celecoxib
1 capsule 200mg QD for 8 days
Other Names:
  • Celebrex

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Associates of New York, LLP

Investigators

  • Principal Investigator: James Aisenberg, MD, Research Associates of New York

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

July 24, 2008

First Submitted That Met QC Criteria

October 22, 2008

First Posted (Estimate)

October 23, 2008

Study Record Updates

Last Update Posted (Estimate)

October 23, 2008

Last Update Submitted That Met QC Criteria

October 22, 2008

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Healing Study
  • GA319181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe