Lesions3: Changes in mRNA Expression Following Exposure to Naproxen

Sponsor

Research Associates of New York, LLP (Other)

Overall Status

Completed

CT.gov ID

NCT01090596

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Naproxen Drug: Placebo	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

Changes in mRNA Expression Following Exposure to Naproxen

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Jun 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Naproxen-Treated

Drug: Naproxen

500mg naproxen, twice daily for 7 days

Placebo Comparator: placebo

Drug: Placebo

1 tab,twice a day for a seven days

Outcome Measures

Primary Outcome Measures

Fold Change in Gene Expression [7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Research Associates of New York, LLP

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01090596

Other Study ID Numbers:

ResearchANY

First Posted:

Mar 22, 2010

Last Update Posted:

Mar 22, 2010

Last Verified:

Mar 1, 2010

Additional relevant MeSH terms:

Naproxen

Study Results

No Results Posted as of Mar 22, 2010