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

• ClinicalTrials.gov Identifier: NCT00778193
• Recruitment Status: Completed
• First Posted: October 23, 2008
• Last Update Posted: October 23, 2008
• Sponsor: Research Associates of New York, LLP
• Information provided by: Research Associates of New York, LLP

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

Eligibility Criteria

• 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.

Contacts and Locations

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. doi: 10.1007/s10620-007-0127-4. Epub 2008 Jan 26.

• Responsible Party: James Asienberg, MD, Research Associates of New York
• ClinicalTrials.gov Identifier: NCT00778193
• Other Study ID Numbers: Healing Study; GA319181
• First Posted: October 23, 2008
• Last Update Posted: October 23, 2008
• Last Verified: October 2008

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; Pathologic Processes; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Aspirin; Celecoxib; Naproxen; Clopidogrel; Anti-Inflammatory Agents, Non-Steroidal; 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; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists