Experimental Biomarker Study for Pain Thresholds

Phase 1

Completed

• Conditions: Pain
• Interventions: Drug: Celecoxib capsules; Drug: Placebo; Drug: V116517 aqueous suspension; Drug: Capsaicin

• Registration Number: NCT02695745
• Lead Sponsor: Purdue Pharma LP

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2016-02
• Study First Submitted: 2016-02-22
• Study First Submitted QC: 2016-02-24
• Last Update Submitted: 2016-02-24
• Study First Posted: 2016-03-01
• Last Update Posted: 2016-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Celecoxib	Celecoxib capsules	Celecoxib capsules; 400 mg (2 capsules of 200 mg each)
Placebo	Placebo	Placebo
Celecoxib	Placebo	Celecoxib capsules; 400 mg (2 capsules of 200 mg each)
V116517	V116517 aqueous suspension	V116517 aqueous suspension; 300 mg
V116517	Placebo	V116517 aqueous suspension; 300 mg
V116517	Capsaicin	V116517 aqueous suspension; 300 mg
Celecoxib	Capsaicin	Celecoxib capsules; 400 mg (2 capsules of 200 mg each)
Placebo	Capsaicin	Placebo

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Erythema at the treated area using Erythema index	3.5 hours post-dose	Erythema at the treated area will be assessed using colorimetry
Evaluation of change in body temperature	Pre-dose and up to 72 hours post-dose	Oral temperature in degrees Celsius (˚C)
Heat Pain tolerance threshold (HPTolTr)	Pre-dose and 3.5 hours post-dose	Mean temperature in degrees Celsius (°C)
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
Heat Pain Threshold (HPTr)	3.5 hours post-dose	Mean temperature in degrees Celsius (°C)
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
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''

Trial Locations

Locations (1)

CCBR A/S; 🇩🇰 Aalborg, Denmark