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

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

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 Overview

• Status: Completed
• Conditions: Neuralgia; Neuralgia, Postherpetic
• Intervention / Treatment: Drug: 2-weeks placebo then gabapentin; Drug: 1-week placebo then gabapentin

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom, L9 7AL
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 2	Drug: 1-week placebo then gabapentin; 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
Placebo Comparator: Sequence 1	Drug: 2-weeks placebo then gabapentin; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS)	Weeks 2 and 4

Secondary Outcome Measures

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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Study Completion (Actual): June 1, 2006

Study Registration Dates

• First Submitted: May 6, 2008
• First Submitted That Met QC Criteria: May 6, 2008
• First Posted (Estimate): May 8, 2008

Study Record Updates

• Last Update Posted (Actual): February 2, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Neuralgia, Postherpetic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: A9451138