search
Back to results

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

Primary Purpose

Osteoarthritis Pain

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Comparator: Iontophoresis and Laser Doppler with ATP
Comparator: Iontophoresis and Laser Doppler with Saline
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Osteoarthritis Pain

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    ATP

    Saline

    Outcomes

    Primary Outcome Measures

    Degree of pain induced by ATP vs. saline iontophoresis
    Increase in blood flow induced by ATP iontophoresis

    Secondary Outcome Measures

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

    Full Information

    First Posted
    June 8, 2009
    Last Updated
    July 29, 2015
    Sponsor
    Merck Sharp & Dohme LLC
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00917696
    Brief Title
    Study to Evaluate ATP-induced Pain and ATP-induced Dermal Vasodilation by Iontophoresis (0000-118)(COMPLETED)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    June 2011 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis Pain

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    ATP
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Saline
    Intervention Type
    Procedure
    Intervention Name(s)
    Comparator: Iontophoresis and Laser Doppler with ATP
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Comparator: Iontophoresis and Laser Doppler with Saline
    Intervention Description
    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 Outcome Measure Information:
    Title
    Degree of pain induced by ATP vs. saline iontophoresis
    Time Frame
    4 minutes
    Title
    Increase in blood flow induced by ATP iontophoresis
    Time Frame
    8 minutes
    Secondary Outcome Measure Information:
    Title
    Test-retest reproducibility and intra-subject variability of AIP and AIDV
    Time Frame
    8 minutes

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor
    Organizational Affiliation
    Merck Sharp & Dohme LLC
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs