Changes in mRNA Expression Following Exposure to Naproxen
Lesions3
1 other identifier
interventional
48
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Apr 2007
Typical duration for not_applicable healthy
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 17, 2010
CompletedFirst Posted
Study publicly available on registry
March 22, 2010
CompletedMarch 22, 2010
March 1, 2010
1.2 years
March 17, 2010
March 18, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Fold Change in Gene Expression
7 days
Study Arms (2)
Naproxen-Treated
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Aisenberg, MD
Research Associates of New York
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 17, 2010
First Posted
March 22, 2010
Study Start
April 1, 2007
Primary Completion
June 1, 2008
Study Completion
July 1, 2008
Last Updated
March 22, 2010
Record last verified: 2010-03