A Study Of The Efficacy Of Gabapentin In Neuropathic Pain Patients As Measured By Quantitative Sensory Testing

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.23 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Neuralgia Neuralgia, Postherpetic

Interventions

2-weeks placebo then gabapentinDRUG

Placebo for 2 weeks followed by gabapentin 300 mg oral capsule once daily titrated over 1 week to gabapentin 600 mg three times daily for 1 week

1-week placebo then gabapentinDRUG

Placebo for 1 week followed by gabapentin 300 mg oral capsule once daily titrated over 1 week to gabapentin 600 mg three times daily for 2 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Pfizer Investigational Site

Liverpool, United Kingdom

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

Subject assessed quality of evoked pain for punctate allodynia

Time frame: Weeks 2 and 4

Pain NRS score for temporal summation to dynamic brush allodynia (soft and coarse brush)

Time frame: Weeks 2 and 4

Pressure pain tolerance threshold

Time frame: Weeks 2 and 4

Pain NRS scores for pressure pain

Time frame: Weeks 2 and 4

Subject assessed quality of evoked pain for temporal summation to dynamic brush allodynia (soft and coarse brush)

Time frame: Weeks 2 and 4

Tactile threshold

Time frame: Week 4

Pressure pain detection threshold

Time frame: Weeks 2 and 4

Area of punctate and dynamic (soft and coarse brush) allodynia

Time frame: Weeks 2 and 4

Pain NRS score for punctate allodynia

Time frame: Weeks 2 and 4

Pain NRS scores for temporal summation to punctate stimuli

Time frame: Weeks 2 and 4

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.