Study to Evaluate ATP-induced Pain and ATP-induced Dermal Vasodilation by Iontophoresis (0000-118)(COMPLETED)

Phase 1

Completed

• Conditions: Osteoarthritis Pain

• Registration Number: NCT00917696
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This study will evaluate ATP-induced Pain (AIP) and ATP-induced dermal vasodilation (AIDV) as target engagement tools for future development of analgesics.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-08
• Study First Submitted QC: 2009-06-08
• Study First Posted: 2009-06-10
• Study Start: 2009-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

Inclusion Criteria

• Subject is in generally good health
• Subject is willing to abstain from smoking within 24 hours of each iontophoresis treatment and limit smoking to 5 or less cigarettes per week during the study

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Exclusion Criteria

• Subject has a history of dermatitis, psoriasis, or eczema
• Subject has active asthma and/or hay fever at the time of the screening visit
• Subject is unable to refrain from use of analgesics within 3 days prior to each treatment period

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Degree of pain induced by ATP vs. saline iontophoresis	4 minutes
Increase in blood flow induced by ATP iontophoresis	8 minutes

Secondary Outcome Measures

Name	Time	Method
Test-retest reproducibility and intra-subject variability of AIP and AIDV	8 minutes