Study of Experimental Models of Pain and Inflammation.
Experimental Inflammatory and Micro-incisional Pain Model Analysis by Gene Expression and Interstitial Fluid Proteomics of Skin Tissue
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 pain
Started Feb 2010
1 active site
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
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 31, 2010
CompletedFirst Posted
Study publicly available on registry
April 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedJune 19, 2013
June 1, 2013
7 months
March 31, 2010
June 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Mechanical and thermal pain measurements, inflammatory COX and Prostaglandin E2 (PGE2) gene expression.
48 hours
Secondary Outcomes (1)
Interleukin-1beta and Interleukin-8 regulation
48 hours
Study Arms (2)
Ibuprophen 800 mg
ACTIVE COMPARATOROral 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.
Placebo
PLACEBO COMPARATOROral placebo administered 24 hours after exposure to UV radiation for the creation of an inflamed lesion, and 2 hours prior to site evaluation.
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Martin Angstlead
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
Related Publications (2)
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.
PMID: 18396374BACKGROUNDAngst 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):1074. doi: 10.3791/1074.
PMID: 19229167BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin S Angst
Stanford University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Anesthesia
Study Record Dates
First Submitted
March 31, 2010
First Posted
April 2, 2010
Study Start
February 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
June 19, 2013
Record last verified: 2013-06