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

NCT ID: NCT00674687

Last Updated: 2021-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-06-30

Brief Summary

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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

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Conditions

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Neuralgia Neuralgia, Postherpetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sequence 1

Group Type PLACEBO_COMPARATOR

2-weeks placebo then gabapentin

Intervention Type DRUG

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

Sequence 2

Group Type EXPERIMENTAL

1-week placebo then gabapentin

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Liverpool, , United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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Other Identifiers

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A9451138

Identifier Type: -

Identifier Source: org_study_id

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