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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00917696
First received: June 8, 2009
Last updated: August 12, 2014
Last verified: August 2014

June 8, 2009
August 12, 2014
October 2009
June 2011   (final data collection date for primary outcome measure)
  • Degree of pain induced by ATP vs. saline iontophoresis [ Time Frame: 4 minutes ] [ Designated as safety issue: No ]
  • Increase in blood flow induced by ATP iontophoresis [ Time Frame: 8 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00917696 on ClinicalTrials.gov Archive Site
Test-retest reproducibility and intra-subject variability of AIP and AIDV [ Time Frame: 8 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate ATP-induced Pain and ATP-induced Dermal Vasodilation by Iontophoresis (0000-118)(COMPLETED)
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

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Osteoarthritis Pain
  • 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.
  • Procedure: 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.
  • Active Comparator: 1
    ATP
    Intervention: Procedure: Comparator: Iontophoresis and Laser Doppler with ATP
  • Placebo Comparator: 2
    Saline
    Intervention: Procedure: Comparator: Iontophoresis and Laser Doppler with Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00917696
0000-118, 2009_600
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP