NCT02695745

Experimental Biomarker Study for Pain Thresholds

Randomized, Double Blind, Positive- Controlled, Three-way Cross-over Human Experimental Biomarker Study of V116517 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Purdue Pharma LP · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	V116517 aqueous suspension	300 mg (approximately 100 mL) aqueous suspension taken orally x 1 dose
DRUG	Celecoxib capsules	400 mg (2 capsules of 200 mg each) taken orally x 1 dose
DRUG	Placebo	Placebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose
DRUG	Capsaicin	1% administered topically

Timeline

• Start date: 2011-09-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2016-03-01
• Last updated: 2016-03-01

Locations

1 site across 1 country: Denmark