Pain
Conditions
Brief summary
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.
Interventions
DRUGV116517 aqueous suspension
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
DRUGPlacebo
Placebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose
DRUGCapsaicin
1% administered topically
Sponsors
Purdue Pharma LP
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
include: 1. Signed informed consent obtained. 2. Males aged 18 to 45, inclusive. 3. Body weight ranging from 50 to 100 kg and BMI ranging from 18 to 32 (kg/m2), inclusive. 4. Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ECG.
Exclusion criteria
include: 1. Current or recent (within 5 years) history of drug or alcohol abuse. 2. History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion. 3. Any history of frequent nausea or emesis regardless of etiology. 4. Any history of allergic-type reactions to sulfonamides, or any experience of asthma, urticarial, or other allergic-type reactions after taking aspirin or other NSAIDS. 5. Subjects who do not develop erythema at the maximum dose of the UVB source (MED determination for UVB model) will be excluded from the study. Other protocol-specific inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application | 3.5 hours post-dose | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heat Pain tolerance threshold (HPTolTr) | Pre-dose and 3.5 hours post-dose | Mean temperature in degrees Celsius (°C) |
| Pressure Pain Threshold (PPTr) | 3.5 hours post-dose | Mean pressure kPA |
| Pressure Pain tolerance threshold (PPTolTr) | 3.5 hours post-dose | Mean pressure kPA |
| Peripheral nociceptor activation using Laser Doppler flowmetry | 3.5 hours post-dose | Peripheral nociceptor activation will be assessed by monitoring cutaneous blood flow using Laser Doppler imaging |
| Heat Pain Threshold (HPTr) | 3.5 hours post-dose | Mean temperature in degrees Celsius (°C) |
| Stimulus-response function to graded von Frey hair stimulation | 3.5 hours post-dose | 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'' |
| Secondary pin-prick hyperalgesic area | 3.5 hours post-dose | 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 |
| Evaluation of change in body temperature | Pre-dose and up to 72 hours post-dose | Oral temperature in degrees Celsius (˚C) |
| Erythema at the treated area using Erythema index | 3.5 hours post-dose | Erythema at the treated area will be assessed using colorimetry |
Countries
Denmark
Outcome results
None listed