Investigation of the antihyperalgesic effect of topical buprenorphine in an UV-B induced inflammatory skin pain model in healthy volunteers - topical buprenorphine in sunbur

Conditions: Volunteer study with healthy volunteers using the UV-B-model as model of hyperalgesia.

Registration Number: EUCTR2005-002159-41-AT

Lead Sponsor: Department of Anaesthesia & General Intensive Care Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 16

Inclusion Criteria

16 healthy volunteers (both male and female, 1:1) will be included in the study. Age 19-40 yrs., body mass index between 19 and 29, drug free, pain free.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy, any disease, ongoing pain, previous exposure to UV-light (sun exposure)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In this study the following hypotheses will be tested: <br>·Topical buprenorphine increases the heat pain threshold in the UV-B induced hyperalgesia of the skin compared to vehicle.<br>·This effect is dose dependent in a dose range between 0.01 and 0.04 % buprenorphine cream.<br>;Secondary Objective: To test the study drug concerning secondary outcome variables:<br>·Cold pain perception threshold (CPPT) in the inflamed area and in normal skin<br>·Stimulus response to different moving innocuous stimuli (Q-tip, cotton wisp, soft brush) in the inflamed area and in normal skin<br>·Heat pain tolerance threshold (HPTT) in the inflamed area and in normal skin. <br>;Primary end point(s): Heat pain threshold after 1 hour of treatment with buprenorphine cream in the sunburn.

Secondary Outcome Measures