Changes in mRNA Expression Following Exposure to Naproxen (Lesions3)

Research Associates of New York, LLP

Status

Completed

Conditions

Healthy

Treatments

Drug: Naproxen

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01090596

ResearchANY

Details and patient eligibility

About

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.

Full description

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

Enrollment

48 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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