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 enrollmentJuly 2004

ConditionsNeuralgia Neuralgia, Postherpetic

Interventions2-weeks placebo then gabapentin 1-week placebo then gabapentin

Drugs2-weeks placebo then gabapentin 1-week placebo then gabapentin

Overview

Phase: Not Applicable
Intervention: 2-weeks placebo then gabapentin
Conditions: Neuralgia
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Enrollment: 23
Locations: 1
Primary Endpoint: Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

July 2004

End Date

June 2006

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Intervention: 2-weeks placebo then gabapentin

Sequence 2

Intervention: 1-week placebo then gabapentin

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)