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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis Pain

Treatments: Procedure: Comparator: Iontophoresis and Laser Doppler with Saline; Procedure: Comparator: Iontophoresis and Laser Doppler with ATP

Study type: Interventional

Funder types: Industry

Identifiers

NCT00917696

2009_600

0000-118

Details and patient eligibility

About

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

Enrollment: 44 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

ATP

Treatment:

Procedure: Comparator: Iontophoresis and Laser Doppler with ATP

2

Placebo Comparator group

Description:

Saline

Treatment:

Procedure: Comparator: Iontophoresis and Laser Doppler with Saline