Changes in mRNA Expression Following Exposure to Naproxen (Lesions3)

Using tissue samples obtained from a previous study, the effect of naproxen on the gene expression profiles of antral mucosal tissue will be assessed. We hypothesize that there will be distinct changes in the gene expression profiles of samples taken from individuals treated with naproxen versus samples taken from individuals treated with placebo.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Naproxen; Drug: Placebo

Detailed Description

We will use microarray technology to quantify the transcriptome-wide changes in gene expression in said-samples.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adult between the ages of 18 and 75 inclusive
• Written informed consent prior to undergoing any study procedures
• A physical examination which reveals no clinically significant abnormalities
• Female subjects of childbearing potential must be taking an acceptable form of contraceptive

Exclusion Criteria:

• Any mucosal breaks within 2 cm of pyloric channel seen on baseline endoscopy
• Any GDU or >5 gastroduodenal erosions at baseline endoscopy
• CXB, CPG, ASA, or NS-NSAID use within the prior 2 weeks
• Previous gastrointestinal ulcer
• Hypersensitivity or allergy to NSAIDs, ASA, CPG, CXB or other contraindication to taking treatments
• Baseline complaints of abdominal pain, nausea, and/or cramping
• Any acid blocking medication including antacids, H-2 receptor blocker within the prior 2 weeks, or PPI use within the prior 30 days
• Corticosteroids use within the prior 60 days
• Any documented bleeding tendency
• Has taken warfarin within the prior 60 days
• Three or greater alcoholic beverages daily
• History of cerebro-vascular event

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo	Drug: Placebo; 1 tab,twice a day for a seven days
Active Comparator: Naproxen-Treated	Drug: Naproxen; 500mg naproxen, twice daily for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fold Change in Gene Expression	7 days

Collaborators and Investigators

• Sponsor: Research Associates of New York, LLP
• Investigators: Principal Investigator: James Aisenberg, MD, Research Associates of New York

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: March 17, 2010
• First Submitted That Met QC Criteria: March 18, 2010
• First Posted (Estimate): March 22, 2010

Study Record Updates

• Last Update Posted (Estimate): March 22, 2010
• Last Update Submitted That Met QC Criteria: March 18, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: ResearchANY