CompletedPhase 1

Experimental Biomarker Study for Pain Thresholds

Denmark37 participantsStarted 2011-09

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexMALE

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Inclusion criteria

✓. Signed informed consent obtained.
✓. Males aged 18 to 45, inclusive.
✓. Body weight ranging from 50 to 100 kg and BMI ranging from 18 to 32 (kg/m2), inclusive.
✓. Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ECG.

Exclusion criteria

✕. Current or recent (within 5 years) history of drug or alcohol abuse.
✕. History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
✕. Any history of frequent nausea or emesis regardless of etiology.
✕. 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.
✕. 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.

What they're measuring

Heat pain tolerance threshold (HPTolTr) in primary hyperalgesic skin after topical capsaicin application

Timeframe: 3.5 hours post-dose

Trial details

NCT IDNCT02695745

SponsorPurdue Pharma LP

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-01

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