NCT00917696

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

1.7 years

First QC Date

June 8, 2009

Last Update Submit

July 29, 2015

Conditions

Osteoarthritis Pain

Outcome Measures

Primary Outcomes (2)

  • Degree of pain induced by ATP vs. saline iontophoresis

    4 minutes

  • Increase in blood flow induced by ATP iontophoresis

    8 minutes

Secondary Outcomes (1)

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

    8 minutes

Study Arms (2)

1

ACTIVE COMPARATOR

ATP

Procedure: Comparator: Iontophoresis and Laser Doppler with ATP

2

PLACEBO COMPARATOR

Saline

Procedure: Comparator: Iontophoresis and Laser Doppler with Saline

Interventions

Comparator: Iontophoresis and Laser Doppler with ATPPROCEDURE

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.

1
Comparator: Iontophoresis and Laser Doppler with SalinePROCEDURE

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.

2

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Adenosine TriphosphateSodium Chloride

Intervention Hierarchy (Ancestors)

Adenine NucleotidesPurine NucleotidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 10, 2009

Study Start

October 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

July 30, 2015

Record last verified: 2015-07