The purpose of this study is to characterize the heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application, and to assess heat pain and mechanical thresholds (eg, pressure pain, stimulus-response) following skin sensitization by UVB (ultraviolet B) irradiation and topical capsaicin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
37
300 mg (approximately 100 mL) aqueous suspension taken orally x 1 dose
400 mg (2 capsules of 200 mg each) taken orally x 1 dose
Placebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose
CCBR A/S
Aalborg, Denmark
Heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application
Mean temperature in degrees Celsius (°C) based on the difference (post-dose and pre-dose) of the differences between the capsaicin at the control arm and the treated arm
Time frame: 3.5 hours post-dose
Heat Pain Threshold (HPTr)
Mean temperature in degrees Celsius (°C)
Time frame: 3.5 hours post-dose
Heat Pain tolerance threshold (HPTolTr)
Mean temperature in degrees Celsius (°C)
Time frame: Pre-dose and 3.5 hours post-dose
Pressure Pain Threshold (PPTr)
Mean pressure kPA
Time frame: 3.5 hours post-dose
Pressure Pain tolerance threshold (PPTolTr)
Mean pressure kPA
Time frame: 3.5 hours post-dose
Peripheral nociceptor activation using Laser Doppler flowmetry
Peripheral nociceptor activation will be assessed by monitoring cutaneous blood flow using Laser Doppler imaging
Time frame: 3.5 hours post-dose
Erythema at the treated area using Erythema index
Erythema at the treated area will be assessed using colorimetry
Time frame: 3.5 hours post-dose
Stimulus-response function to graded von Frey hair stimulation
The mean pain intensity of the stimulations on a '0-10' visual analog scale (VAS), where '0' indicates ''no pain" and '10' indicates '' the most intense pain imaginable''
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1% administered topically
Time frame: 3.5 hours post-dose
Secondary pin-prick hyperalgesic area
The area will be assessed using a 60 g weighted von Frey hair, and subjects are asked to report when the sensation changes to a "different sensation", "unpleasant" or "burning pain" sensation
Time frame: 3.5 hours post-dose
Evaluation of change in body temperature
Oral temperature in degrees Celsius (˚C)
Time frame: Pre-dose and up to 72 hours post-dose