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
  Purpose

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 Intervention
Healthy
Drug: Naproxen
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Changes in mRNA Expression Following Exposure to Naproxen

Resource links provided by NLM:


Further study details as provided by Research Associates of New York, LLP:

Primary Outcome Measures:
  • Fold Change in Gene Expression [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: April 2007
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01090596

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

No publications provided

Responsible Party: James Aisenberg, MD, Research Associates of New York
ClinicalTrials.gov Identifier: NCT01090596     History of Changes
Other Study ID Numbers: ResearchANY
Study First Received: March 17, 2010
Last Updated: March 18, 2010
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014