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CompletedNCT00917696Updated Jul 30, 2015

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

A Phase 1 interventional study of Comparator: Iontophoresis and Laser Doppler with ATP and Comparator: Iontophoresis and Laser Doppler with Saline in Osteoarthritis Pain, sponsored by Merck Sharp & Dohme LLC. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-30.

Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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

02

Conditions studied

  • Osteoarthritis Pain

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03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 44 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (actual)

Study arms

  • Active comparator
    1

    ATP

    Procedure: Comparator: Iontophoresis and Laser Doppler with ATP

  • Placebo comparator
    2

    Saline

    Procedure: Comparator: Iontophoresis and Laser Doppler with Saline

Interventions

  • ProcedureComparator: 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.

  • ProcedureComparator: 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.

06

What researchers measure

Primary outcomes

  1. Degree of pain induced by ATP vs. saline iontophoresis

    Time frame: 4 minutes

  2. Increase in blood flow induced by ATP iontophoresis

    Time frame: 8 minutes

Secondary outcomes

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

    Time frame: 8 minutes

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00917696
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jun 10, 2009
Start date
Oct 2009
Primary completion
Jun 2011
Completion
Jun 2011
Last update
Jul 30, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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