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

Osteoarthritis Pain Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917696
• Other study ID #: 0000-118
• Secondary ID: 2009_600
• Status: Completed
• Phase: Phase 1
• First received: June 8, 2009
• Last updated: July 29, 2015
• Start date: October 2009
• Est. completion date: June 2011

Study information

• Verified date: July 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Osteoarthritis Pain

Intervention

Procedure:
• Comparator: Iontophoresis and Laser Doppler with ATP
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
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of pain induced by ATP vs. saline iontophoresis		4 minutes	No
Primary	Increase in blood flow induced by ATP iontophoresis		8 minutes	No
Secondary	Test-retest reproducibility and intra-subject variability of AIP and AIDV		8 minutes	No