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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00674687
First Posted: May 8, 2008
Last Update Posted: May 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • 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 ]
  • Subject assessed quality of evoked pain for temporal summation to punctate stimuli [ Time Frame: Weeks 2 and 4 ]
  • Neuropathic pain scale [ Time Frame: Week 4 ]
  • Test-day global pain scale [ Time Frame: Week 4 ]
  • Pain diary card [ Time Frame: Week 4 ]
  • Pain NRS score for dynamic brush allodynia (soft brush) [ Time Frame: Weeks 2 and 4 ]
  • Subject assessed quality of evoked pain for dynamic brush allodynia (soft brush) [ Time Frame: Weeks 2 and 4 ]
  • Presence of metabonomic biomarkers [ Time Frame: Weeks 1 and 4 ]
  • Physical examination [ Time Frame: 1 week after 4-week treatment period ]
  • Adverse events [ Time Frame: Throughout study duration ]
  • Clinical laboratory tests [ Time Frame: 1 week after 4-week treatment period ]
  • Subject assessed quality of pressure pain [ Time Frame: Weeks 2 and 4 ]

Enrollment: 23
Study Start Date: July 2004
Study Completion Date: June 2006
Arms Assigned Interventions
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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00674687     History of Changes
Other Study ID Numbers: A9451138
First Submitted: May 6, 2008
First Posted: May 8, 2008
Last Update Posted: May 12, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Neuralgia
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents