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OpenTrials
Completed

NCT Number: NCT00778193

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Associates of New York

New York, 10075, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Naproxen

Drug

1 tablet 500mg BID for 8 days

Other names: naprosyn, naproxen sodium, Aleve, Anaprox, Miranax, Naprogesic, Naprelan, Proxen, Synflex

Aspirin

Drug

1 tablet 81mg QD for 8 days

Other names: ASA, Bayer

Celecoxib

Drug

1 capsule 200mg QD for 8 days

Other names: Celebrex

clopidogrel

Drug

Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days

Other names: Plavix

Placebo

Drug

1 capsule BID for 8 days

Other names: sugar pill

Sponsors and collaborators

Lead sponsor

Research Associates of New York, LLP

Other

Registry information

Official study title

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

Acronym: Lesions2

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 23, 2008
Registry last updated
Oct 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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