Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers - Full Text View

Sponsored by:	Research Associates of New York, LLP
Information provided by:	Research Associates of New York, LLP
ClinicalTrials.gov Identifier:	NCT00778193

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 IV

MedlinePlus related topics: Peptic Ulcer

Drug Information available for: Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide Naproxen Naproxen sodium Acetylsalicylic acid Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

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

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: Placebo Comparator	Drug: Placebo 1 capsule BID for 8 days
Naproxen: Active Comparator	Drug: Naproxen 1 tablet 500mg BID for 8 days
Aspirin: Experimental	Drug: Aspirin 1 tablet 81mg QD for 8 days
Clopidogrel: Experimental	Drug: Clopidogrel Day 0: 4 tablets QD for 1 day; Days 1-7: 1 tablet QD for 7 days
Celecoxib: Experimental	Drug: Celecoxib 1 capsule 200mg QD for 8 days

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:

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.

Responsible Party:	Research Associates of New York ( James Asienberg, MD )
Study ID Numbers:	Healing Study, GA319181
Study First Received:	July 24, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00778193
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

Study placed in the following topic categories:

Naproxen
Celecoxib
Stomach Diseases
Digestive System Diseases
Aspirin
Gastrointestinal Diseases

Clopidogrel
Ulcer
Intestinal Diseases
Duodenal Diseases
Peptic Ulcer

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Fibrinolytic Agents
Cardiovascular Agents
Gout Suppressants
Pharmacologic Actions
Fibrin Modulating Agents

Pathologic Processes
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009