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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00674687

Purpose

The purpose of this study is to assess the reproducibility and the effect of gabapentin on quantitative sensory testing assessments in neuropathic pain subjects.

Condition	Intervention
Neuralgia Neuralgia, Postherpetic	Drug: 2-weeks placebo then gabapentin Drug: 1-week placebo then gabapentin

MedlinePlus related topics: Shingles

Drug Information available for: Gabapentin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Pfizer:

Primary Outcome Measures:

Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS) [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Subject assessed quality of evoked pain for punctate allodynia [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Pain NRS score for temporal summation to dynamic brush allodynia (soft and coarse brush) [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Pressure pain tolerance threshold [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Pain NRS scores for pressure pain [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Subject assessed quality of evoked pain for temporal summation to dynamic brush allodynia (soft and coarse brush) [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Tactile threshold [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Pressure pain detection threshold [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Area of punctate and dynamic (soft and coarse brush) allodynia [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Pain NRS score for punctate allodynia [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Pain NRS scores for temporal summation to punctate stimuli [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Subject assessed quality of evoked pain for temporal summation to punctate stimuli [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Neuropathic pain scale [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Test-day global pain scale [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Pain diary card [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Pain NRS score for dynamic brush allodynia (soft brush) [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Subject assessed quality of evoked pain for dynamic brush allodynia (soft brush) [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]
Presence of metabonomic biomarkers [ Time Frame: Weeks 1 and 4 ] [ Designated as safety issue: No ]
Physical examination [ Time Frame: 1 week after 4-week treatment period ] [ Designated as safety issue: Yes ]
Adverse events [ Time Frame: Throughout study duration ] [ Designated as safety issue: Yes ]
Clinical laboratory tests [ Time Frame: 1 week after 4-week treatment period ] [ Designated as safety issue: Yes ]
Subject assessed quality of pressure pain [ Time Frame: Weeks 2 and 4 ] [ Designated as safety issue: No ]

Enrollment:	23
Study Start Date:	July 2004
Study Completion Date:	June 2006

Arms	Assigned Interventions
Sequence 1: Placebo Comparator	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
Sequence 2: Experimental	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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00674687

Locations

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

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A9451138
Study First Received:	May 6, 2008
Last Updated:	May 8, 2008
ClinicalTrials.gov Identifier:	NCT00674687
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Neuralgia, Postherpetic
Excitatory Amino Acids
Calcium, Dietary
Signs and Symptoms
Neuromuscular Diseases

Neuralgia
Gabapentin
Peripheral Nervous System Diseases
Neurologic Manifestations
Pain

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Cardiovascular Agents

Antimanic Agents
Pharmacologic Actions
Membrane Transport Modulators
Sensory System Agents
Therapeutic Uses
Anti-Anxiety Agents
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on January 16, 2009