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

This study has been completed.
Sponsor:
Information provided by:
Research Associates of New York, LLP
ClinicalTrials.gov Identifier:
NCT00778193
First received: July 24, 2008
Last updated: October 22, 2008
Last verified: October 2008

July 24, 2008
October 22, 2008
October 2007
March 2008   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00778193 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers
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.

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.

Interventional
Phase 4
Not Provided
Gastroduodenal Ulcer
  • Drug: Naproxen
    1 tablet 500mg BID for 8 days
    Other Names:
    • naprosyn
    • naproxen sodium
    • Aleve
    • Anaprox
    • Miranax
    • Naprogesic
    • Naprelan
    • Proxen
    • Synflex
  • Drug: Aspirin
    1 tablet 81mg QD for 8 days
    Other Names:
    • ASA
    • Bayer
  • Drug: Celecoxib
    1 capsule 200mg QD for 8 days
    Other Name: Celebrex
  • Drug: Clopidogrel
    Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days
    Other Name: Plavix
  • Drug: Placebo
    1 capsule BID for 8 days
    Other Name: sugar pill
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Naproxen
    Intervention: Drug: Naproxen
  • Experimental: Aspirin
    Intervention: Drug: Aspirin
  • Experimental: Clopidogrel
    Intervention: Drug: Clopidogrel
  • Experimental: Celecoxib
    Intervention: Drug: Celecoxib
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. Epub 2008 Jan 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
March 2008
March 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00778193
Healing Study, GA319181
No
James Asienberg, MD, Research Associates of New York
Research Associates of New York, LLP
Not Provided
Principal Investigator: James Aisenberg, MD Research Associates of New York
Research Associates of New York, LLP
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP