Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00674687
First received: May 6, 2008
Last updated: May 8, 2008
Last verified: May 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 ] [ 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided

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

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

ClinicalTrials.gov processed this record on November 25, 2014