Clinical trial NCT00674687: A Study Of The Efficacy Of Gabapentin In Neuropathic Pain Patients As Measured By Quantitative Sensory Testing
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuralgia
Neuralgia, Postherpetic
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-05-08
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS)
timeFrame: Weeks 2 and 4
Secondary outcomes:
measure: Subject assessed quality of evoked pain for punctate allodynia
timeFrame: Weeks 2 and 4
measure: Pain NRS score for temporal summation to dynamic brush allodynia (soft and coarse brush)
timeFrame: Weeks 2 and 4
measure: Pressure pain tolerance threshold
timeFrame: Weeks 2 and 4
measure: Pain NRS scores for pressure pain
timeFrame: Weeks 2 and 4
measure: Subject assessed quality of evoked pain for temporal summation to dynamic brush allodynia (soft and coarse brush)
timeFrame: Weeks 2 and 4
measure: Tactile threshold
timeFrame: Week 4
measure: Pressure pain detection threshold
timeFrame: Weeks 2 and 4
measure: Area of punctate and dynamic (soft and coarse brush) allodynia
timeFrame: Weeks 2 and 4
measure: Pain NRS score for punctate allodynia
timeFrame: Weeks 2 and 4
measure: Pain NRS scores for temporal summation to punctate stimuli
timeFrame: Weeks 2 and 4
measure: Subject assessed quality of evoked pain for temporal summation to punctate stimuli
timeFrame: Weeks 2 and 4
measure: Neuropathic pain scale
timeFrame: Week 4
measure: Test-day global pain scale
timeFrame: Week 4
measure: Pain diary card
timeFrame: Week 4
measure: Pain NRS score for dynamic brush allodynia (soft brush)
timeFrame: Weeks 2 and 4
measure: Subject assessed quality of evoked pain for dynamic brush allodynia (soft brush)
timeFrame: Weeks 2 and 4
measure: Presence of metabonomic biomarkers
timeFrame: Weeks 1 and 4
measure: Physical examination
timeFrame: 1 week after 4-week treatment period
measure: Adverse events
timeFrame: Throughout study duration
measure: Clinical laboratory tests
timeFrame: 1 week after 4-week treatment period
measure: Subject assessed quality of pressure pain
timeFrame: Weeks 2 and 4
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: