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

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

Completed

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Key information

Conditions

Osteoarthritis Pain

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Comparator: Iontophoresis and Laser Doppler with ATP

Procedure

Iontophoresis treatments with 10 mM ATP (adenosine triphosphate) solution and a current of 0.8 or 1.2 mA. Iontophoresis treatments will last 4 minutes. Laser doppler will be used during the iontophoresis treatments to measure dermal blood flow.

Comparator: Iontophoresis and Laser Doppler with Saline

Procedure

Iontophoresis treatments with 20 mM saline solution and a current of 0.8 or 1.2 mA. Iontophoresis treatments will last 4 minutes. Laser doppler will be used during the iontophoresis treatments to measure dermal blood flow.

Primary outcomes

Degree of pain induced by ATP vs. saline iontophoresis

Time frame: 4 minutes
Increase in blood flow induced by ATP iontophoresis

Time frame: 8 minutes

Secondary outcomes

Test-retest reproducibility and intra-subject variability of AIP and AIDV

Time frame: 8 minutes

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled, Crossover Clinical Trial to Evaluate the Effects of ATP-Induced Pain (AIP) and ATP-induced Dermal Vasodilation (AIDV) by Iontophoresis in Healthy Subjects

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jun 10, 2009
Registry last updated: Jul 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed