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
About this trial
This is an interventional diagnostic trial for Osteoarthritis Pain
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
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
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)
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