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”

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

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• 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
• 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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Sequence 1
• Experimental: Sequence 2

Primary Measures

• Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS)
  • Time Frame: Weeks 2 and 4
    Safety Issue?: No

Secondary Measures

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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00674687

Study ID Number: A9451138

ClinicalTrials.gov Identifier: NCT00674687

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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