Changes in mRNA Expression Following Exposure to Naproxen (Lesions3)
This study has been completed.
Sponsor:
Research Associates of New York, LLP
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
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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 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 May 19, 2013