Study of Experimental Models of Pain and Inflammation.
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Ibuprofen
800 mg oral one time only
Other Names:
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| 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 Names:
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Outcome Measures
Primary Outcome Measures
- Mechanical and thermal pain measurements, inflammatory COX and Prostaglandin E2 (PGE2) gene expression. [48 hours]
Secondary Outcome Measures
- Interleukin-1beta and Interleukin-8 regulation [48 hours]
Eligibility Criteria
Criteria
Inclusion Criteria:1) Age 18-60 2) Skin type II or III according to classification of Fitzpatrick 3) Negative pregnancy test (women of childbearing potential) 4) Willing and able to sign an informed consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization and to comply with study procedures
Exclusion Criteria:1) History of acute or chronic illness that may hinder study procedures or confuse interpretation of the data (e.g. dermatological, neurological, psychiatric or addictive diseases) 2) Clinically significant cardiovascular, pulmonary, hepatic or renal diseases 3) Major bodily injury within 3 months of study participation 4) Surgery within 3 months of study participation 5) Pregnancy or breast-feeding 6) Intake of prescription drugs with anti/pro-inflammatory action 7) Intake of prescription drugs with anti/pro-analgesic action 8) Inability to abstain from any anti/pro inflammatory drugs during the 24-hour period preceding a study session 9) Inability to abstain from any anti/pro-analgesic drugs during the 24-hour period preceding a study session 10) Prior medical history that would contraindicate the use of NSAID, or previous negative reaction to NSAIDs or aspirin 11) Inability to obtain at least 6 hours of sleep during the night preceding a study session
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University School of Medicine | Stanford | California | United States | 94305 |
Sponsors and Collaborators
- Martin Angst
Investigators
- Principal Investigator: Martin S Angst, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
- Angst MS, Clark JD, Carvalho B, Tingle M, Schmelz M, Yeomans DC. Cytokine profile in human skin in response to experimental inflammation, noxious stimulation, and administration of a COX-inhibitor: a microdialysis study. Pain. 2008 Sep 30;139(1):15-27. doi: 10.1016/j.pain.2008.02.028. Epub 2008 Apr 8.
- Angst MS, Tingle M, Schmelz M, Carvalho B, Yeomans DC. Human in-vivo bioassay for the tissue-specific measurement of nociceptive and inflammatory mediators. J Vis Exp. 2008 Dec 1;(22). pii: 1074. doi: 10.3791/1074.
- SU-03012010-5102