Changes in mRNA Expression Following Exposure to Naproxen (Lesions3)

This study has been completed.
Sponsor:
Information provided by:
Research Associates of New York, LLP
ClinicalTrials.gov Identifier:
NCT01090596
First received: March 17, 2010
Last updated: March 18, 2010
Last verified: March 2010

March 17, 2010
March 18, 2010
April 2007
June 2008   (final data collection date for primary outcome measure)
Fold Change in Gene Expression [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01090596 on ClinicalTrials.gov Archive Site
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Changes in mRNA Expression Following Exposure to Naproxen
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.

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

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Healthy
  • Drug: Naproxen
    500mg naproxen, twice daily for 7 days
  • Drug: Placebo
    1 tab,twice a day for a seven days
  • Active Comparator: Naproxen-Treated
    Intervention: Drug: Naproxen
  • Placebo Comparator: placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
July 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01090596
ResearchANY
No
James Aisenberg, MD, Research Associates of New York
Research Associates of New York, LLP
Not Provided
Principal Investigator: James Aisenberg, MD Research Associates of New York
Research Associates of New York, LLP
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP