Changes in mRNA Expression Following Exposure to Naproxen

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01090596

Acronym

Lesions3

Enrollment

Registered

2010-03-22

Start date

2007-04-30

Completion date

2008-07-31

Last updated

2010-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Detailed description

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

Interventions

DRUGNaproxen

500mg naproxen, twice daily for 7 days

DRUGPlacebo

1 tab,twice a day for a seven days

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Fold Change in Gene Expression	7 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026