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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00917696
First Posted: June 10, 2009
Last Update Posted: July 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
June 8, 2009
June 10, 2009
July 30, 2015
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 ]
  • Increase in blood flow induced by ATP iontophoresis [ Time Frame: 8 minutes ]
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 ]
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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Belgium
 
NCT00917696
0000-118
2009_600
No
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
July 2015

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