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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastroduodenal Ulcer
 Drug: Naproxen
Drug: Aspirin
Drug: Celecoxib
Drug: Clopidogrel
Drug: Placebo
 Phase 4

Study Type: Interventional
Official Title: A Randomized, Blinded, Placebo-Controlled Study of the Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on Gastroduodenal Healing

Resource links provided by NLM:

MedlinePlus related topics: Peptic Ulcer
U.S. FDA Resources

Further study details as provided by Research Associates of New York, LLP:

Enrollment: 125
Study Start Date: October 2007
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: Placebo
1 capsule BID for 8 days
Other Name: sugar pill
Active Comparator: Naproxen Drug: Naproxen
1 tablet 500mg BID for 8 days
Other Names:
  • naprosyn
  • naproxen sodium
  • Aleve
  • Anaprox
  • Miranax
  • Naprogesic
  • Naprelan
  • Proxen
  • Synflex
Experimental: Aspirin Drug: Aspirin
1 tablet 81mg QD for 8 days
Other Names:
  • ASA
  • Bayer
Experimental: Clopidogrel Drug: Clopidogrel
Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days
Other Name: Plavix
Experimental: Celecoxib Drug: Celecoxib
1 capsule 200mg QD for 8 days
Other Name: Celebrex

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778193

Locations
United States, New York
Research Associates of New York
New York, New York, United States, 10075
Sponsors and Collaborators
Research Associates of New York, LLP
Investigators
Principal Investigator: James Aisenberg, MD Research Associates of New York
  More Information

Publications:

Responsible Party: James Asienberg, MD, Research Associates of New York
ClinicalTrials.gov Identifier: NCT00778193     History of Changes
Other Study ID Numbers: Healing Study, GA319181
Study First Received: July 24, 2008
Last Updated: October 22, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Research Associates of New York, LLP:
NSAID
ulcer
gastroduodenal ulcer
naproxen
aspirin
ASA
celecoxib
 clopidogrel
healing
Cyclooxygenase 2 Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Platelet Aggregation Inhibitors
Wound Healing

Additional relevant MeSH terms:
Peptic Ulcer
Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Aspirin
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Celecoxib
Ticlopidine
Clopidogrel
Platelet Aggregation Inhibitors
 Anti-Inflammatory Agents
Cyclooxygenase 2 Inhibitors
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents

ClinicalTrials.gov processed this record on June 18, 2013