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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:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00917696
First received: June 8, 2009
Last updated: July 13, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Osteoarthritis Pain
 Procedure: Comparator: Iontophoresis and Laser Doppler with ATP
Procedure: Comparator: Iontophoresis and Laser Doppler with Saline
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Test-retest reproducibility and intra-subject variability of AIP and AIDV [ Time Frame: 8 minutes ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: October 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
ATP
 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.
Placebo Comparator: 2
Saline
 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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00917696

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00917696     History of Changes
Other Study ID Numbers: MK-0000-118, 2009_600
Study First Received: June 8, 2009
Last Updated: July 13, 2012
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 23, 2013