A Human In-vivo Model for the Detection of Inflammatory and Nociceptive Biomarkers
Proof-of-concept Study for Bio-marker Assay Validation in Humans
1 other identifier
interventional
13
1 country
1
Brief Summary
This study aims to establish a novel approach assisting the rational development of analgesic and anti-inflammatory drugs. In a first step we will test in healthy human volunteers whether proteins mediating inflammation and pain can be detected in an experimentally induced inflammatory skin lesion. Fluids that will be used to detect such proteins will be collected from the inflamed skin site via small porous catheters. We wish to establish the expression pattern of different proteins and correlate it with various tests assessing pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
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
First Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedJune 19, 2013
June 1, 2013
September 14, 2005
June 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Cytokine-release profile in response to inflammation, noxious heat, and asministration of a COX-inhibitor
Interventions
Eligibility Criteria
You may not qualify if:
- \. Consumption of analgesic drugs. 3. Hypersensitivity to sunlight.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Martin Angstlead
Study Sites (1)
Stanford University School of Medicine
Stanford, California, 94305, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin S Angst
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Anesthesia
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 16, 2005
Last Updated
June 19, 2013
Record last verified: 2013-06