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Changes in mRNA Expression Following Exposure to Naproxen (Lesions3)

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ClinicalTrials.gov Identifier: NCT01090596
Recruitment Status : Completed
First Posted : March 22, 2010
Last Update Posted : March 22, 2010
Sponsor:
Information provided by:
Research Associates of New York, LLP

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 Not Applicable

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

Study Type : Interventional  (Clinical Trial)
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 : April 2007
Actual Primary Completion Date : June 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Fold Change in Gene Expression [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01090596


Sponsors and Collaborators
Research Associates of New York, LLP
Investigators
Principal Investigator: James Aisenberg, MD Research Associates of New York

Responsible Party: James Aisenberg, MD, Research Associates of New York
ClinicalTrials.gov Identifier: NCT01090596     History of Changes
Other Study ID Numbers: ResearchANY
First Posted: March 22, 2010    Key Record Dates
Last Update Posted: March 22, 2010
Last Verified: March 2010

Additional relevant MeSH terms:
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action