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

Condition(s) targeted: Neuralgia; Neuralgia, Postherpetic

Intervention: 2-weeks placebo then gabapentin (Drug); 1-week placebo then gabapentin (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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

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

Primary outcome: Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS)

Secondary outcome:

Subject assessed quality of evoked pain for punctate allodynia

Pain NRS score for temporal summation to dynamic brush allodynia (soft and coarse brush)

Pressure pain tolerance threshold

Pain NRS scores for pressure pain

Subject assessed quality of evoked pain for temporal summation to dynamic brush allodynia (soft and coarse brush)

Tactile threshold

Pressure pain detection threshold

Area of punctate and dynamic (soft and coarse brush) allodynia

Pain NRS score for punctate allodynia

Pain NRS scores for temporal summation to punctate stimuli

Subject assessed quality of evoked pain for temporal summation to punctate stimuli

Neuropathic pain scale

Test-day global pain scale

Pain diary card

Pain NRS score for dynamic brush allodynia (soft brush)

Subject assessed quality of evoked pain for dynamic brush allodynia (soft brush)

Presence of metabonomic biomarkers

Physical examination

Adverse events

Clinical laboratory tests

Subject assessed quality of pressure pain

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Pfizer Investigational Site, Liverpool L9 7AL, United Kingdom

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting

Starting date: July 2004
Ending date: June 2006
Last updated: May 8, 2008