Changes in mRNA Expression Following Exposure to Naproxen (Lesions3)

March 18, 2010 updated by: Research Associates of New York, LLP
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

Intervention / Treatment

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Research Associates of New York, LLP

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Other Study ID Numbers

  • ResearchANY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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