- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00917696
Study to Evaluate ATP-induced Pain and ATP-induced Dermal Vasodilation by Iontophoresis (0000-118)(COMPLETED)
July 29, 2015 updated by: Merck Sharp & Dohme LLC
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Degree of pain induced by ATP vs. saline iontophoresis
Time Frame: 4 minutes
|
4 minutes
|
Increase in blood flow induced by ATP iontophoresis
Time Frame: 8 minutes
|
8 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Test-retest reproducibility and intra-subject variability of AIP and AIDV
Time Frame: 8 minutes
|
8 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
June 8, 2009
First Submitted That Met QC Criteria
June 8, 2009
First Posted (Estimate)
June 10, 2009
Study Record Updates
Last Update Posted (Estimate)
July 30, 2015
Last Update Submitted That Met QC Criteria
July 29, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000-118
- 2009_600
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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