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Clinical Trials/NCT00674687
NCT00674687CompletedNot Applicable

A Randomized Double-Blind, Placebo-Controlled, Crossover Study To Assess The Reproducibility And The Effect Of Gabapentin On Quantitative Sensory Testing In Neuropathic Pain Patients

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 site in 1 country23 target enrollmentStarted: July 2004Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
23
Locations
1
Primary Endpoint
Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The purpose of this study is to assess the reproducibility and the effect of gabapentin on quantitative sensory testing assessments in neuropathic pain subjects.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Neuropathic pain of peripheral origin as a consequence of either post-herpetic neuralgia or post-traumatic neuropathic pain
  • •Well-defined skin area of mechanical allodynia to punctate (von Frey filament) stimuli
  • •Pain intensity score of ≥ 4/10 for von Frey filament-evoked allodynia at the skin area

Exclusion Criteria

  • •Patients who have undergone neurolytic or neurosurgical therapy, including skin excisions, for neuropathic pain
  • •Patients who have trigeminal neuralgia, central pain, chronic radiculopathy, or peripheral neuropathy of non-mechanical or unknown origin
  • •Patients with any other co-existing pain which cannot be differentiated from the neuropathic pain of peripheral origin

Arms & Interventions

Sequence 1

Placebo Comparator

Intervention: 2-weeks placebo then gabapentin (Drug)

Sequence 2

Experimental

Intervention: 1-week placebo then gabapentin (Drug)

Outcomes

Primary Outcomes

Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS)

Time Frame: Weeks 2 and 4

Secondary Outcomes

  • Presence of metabonomic biomarkers(Weeks 1 and 4)
  • Tactile threshold(Week 4)
  • Pain NRS score for temporal summation to dynamic brush allodynia (soft and coarse brush)(Weeks 2 and 4)
  • Subject assessed quality of evoked pain for temporal summation to dynamic brush allodynia (soft and coarse brush)(Weeks 2 and 4)
  • Pain NRS score for punctate allodynia(Weeks 2 and 4)
  • Test-day global pain scale(Week 4)
  • Pain NRS score for dynamic brush allodynia (soft brush)(Weeks 2 and 4)
  • Adverse events(Throughout study duration)
  • Subject assessed quality of evoked pain for punctate allodynia(Weeks 2 and 4)
  • Pressure pain detection threshold(Weeks 2 and 4)
  • Area of punctate and dynamic (soft and coarse brush) allodynia(Weeks 2 and 4)
  • Subject assessed quality of evoked pain for temporal summation to punctate stimuli(Weeks 2 and 4)
  • Pressure pain tolerance threshold(Weeks 2 and 4)
  • Pain NRS scores for pressure pain(Weeks 2 and 4)
  • Pain NRS scores for temporal summation to punctate stimuli(Weeks 2 and 4)
  • Neuropathic pain scale(Week 4)
  • Pain diary card(Week 4)
  • Subject assessed quality of evoked pain for dynamic brush allodynia (soft brush)(Weeks 2 and 4)
  • Physical examination(1 week after 4-week treatment period)
  • Clinical laboratory tests(1 week after 4-week treatment period)
  • Subject assessed quality of pressure pain(Weeks 2 and 4)

Investigators

Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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