A Human In-vivo Model for the Detection of Inflammatory and Nociceptive Biomarkers
This study has been completed.
Information provided by (Responsible Party):
Martin Angst, Stanford University
First received: September 14, 2005
Last updated: June 18, 2013
Last verified: June 2013
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.
Intervention Model: Crossover Assignment
Primary Purpose: Diagnostic
||Proof-of-concept Study for Bio-marker Assay Validation in Humans
Primary Outcome Measures:
- Cytokine-release profile in response to inflammation, noxious heat, and asministration of a COX-inhibitor
|Ages Eligible for Study:
||21 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Inclusion Criteria:1. Age between 21-60. 2. Skin type II or III according to the classification of Fitzpatrick (II: fair skin, always burns, sometimes tans, III: medium skin, sometimes burns, always tans).
Exclusion Criteria:1. History of a significant systemic disease, a dermatological disease, bleeding disorder, or chronic pain.
2. Consumption of analgesic drugs. 3. Hypersensitivity to sunlight.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00186563
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
||Martin S Angst
No publications provided
||Martin Angst, Professor of Anesthesia, Stanford University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 14, 2005
||June 18, 2013
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 27, 2015