Study of Experimental Models of Pain and Inflammation.
The experimental pain model studied in this proposal show characteristics of an inflamed wound with a pro-inflammatory response. This study will help discover candidate genetic and/or proteomic pain biomarkers that could provide objective and mechanism based tests to diagnose, monitor or quantify pain. We also hope to determine the measurable effects of a known non-steroidal anti-inflammatory drug (NSAID) on biomarkers of pain and inflammation.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Experimental Inflammatory and Micro-incisional Pain Model Analysis by Gene Expression and Interstitial Fluid Proteomics of Skin Tissue|
- Mechanical and thermal pain measurements, inflammatory COX and Prostaglandin E2 (PGE2) gene expression. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Interleukin-1beta and Interleukin-8 regulation [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
|Study Start Date:||February 2010|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Ibuprophen 800 mg
Oral ibuprofen 800 mg, administered 24 hours after exposure to UV radiation for the creation of an inflamed lesion, and 2 hours prior to site evaluation.
800 mg oral one time only
Other Name: Ibuprofen, generic
Placebo Comparator: Placebo
Oral placebo administered 24 hours after exposure to UV radiation for the creation of an inflamed lesion, and 2 hours prior to site evaluation.
Drug: Placebo tablet
Placebo tablet oral one time only
Other Name: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097902
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Martin S Angst||Stanford University|