ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00778193
Recruitment Status : Completed
First Posted : October 23, 2008
Last Update Posted : October 23, 2008
Sponsor:
Information provided by:
Research Associates of New York, LLP

Brief Summary:
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 or disease Intervention/treatment Phase
Gastroduodenal Ulcer Drug: Naproxen Drug: Aspirin Drug: Celecoxib Drug: Clopidogrel Drug: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 125 participants
Official Title: A Randomized, Blinded, Placebo-Controlled Study of the Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on Gastroduodenal Healing
Study Start Date : October 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer

Arm Intervention/treatment
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





Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: October 23, 2008
Last Verified: October 2008

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

Additional relevant MeSH terms:
Aspirin
Ulcer
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Celecoxib
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Ticlopidine
Clopidogrel
Platelet Aggregation Inhibitors
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists