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

Not Applicable

Completed

• Conditions: Neuralgia; Neuralgia, Postherpetic
• Interventions: Drug: 1-week placebo then gabapentin; Drug: 2-weeks placebo then gabapentin

• Registration Number: NCT00674687
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study Completion: 2006-06
• Status Verified: 2008-05
• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-06
• Study First Posted: 2008-05-08
• Last Update Submitted: 2021-02-01
• Last Update Posted: 2021-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 2	1-week placebo then gabapentin	-
Sequence 1	2-weeks placebo then gabapentin	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
Presence of metabonomic biomarkers	Weeks 1 and 4
Subject assessed quality of evoked pain for dynamic brush allodynia (soft brush)	Weeks 2 and 4
Tactile threshold	Week 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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Liverpool, United Kingdom