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OpenTrials
Completed

NCT Number: NCT01090596

Changes in mRNA Expression Following Exposure to Naproxen

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.

Completed

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Key information

Conditions

Healthy

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Naproxen

Drug

500mg naproxen, twice daily for 7 days

Placebo

Drug

1 tab,twice a day for a seven days

Primary outcomes

  1. Fold Change in Gene Expression

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Research Associates of New York, LLP

Other

Registry information

Acronym: Lesions3

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 22, 2010
Registry last updated
Mar 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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