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Completed

NCT Number: NCT00674687

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

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

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Key information

Conditions

Neuralgia Nervous System Diseases Neuralgia, Postherpetic Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pfizer Investigational Site

Liverpool, L9 7AL, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2-weeks placebo then gabapentin

Drug

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

1-week placebo then gabapentin

Drug

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

Primary outcomes

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

    Time frame: Weeks 2 and 4

Secondary outcomes

  1. Subject assessed quality of evoked pain for punctate allodynia

    Time frame: Weeks 2 and 4

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

    Time frame: Weeks 2 and 4

  3. Pressure pain tolerance threshold

    Time frame: Weeks 2 and 4

  4. Pain NRS scores for pressure pain

    Time frame: Weeks 2 and 4

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

    Time frame: Weeks 2 and 4

  6. Tactile threshold

    Time frame: Week 4

  7. Pressure pain detection threshold

    Time frame: Weeks 2 and 4

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

    Time frame: Weeks 2 and 4

  9. Pain NRS score for punctate allodynia

    Time frame: Weeks 2 and 4

  10. Pain NRS scores for temporal summation to punctate stimuli

    Time frame: Weeks 2 and 4

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

    Time frame: Weeks 2 and 4

  12. Neuropathic pain scale

    Time frame: Week 4

  13. Test-day global pain scale

    Time frame: Week 4

  14. Pain diary card

    Time frame: Week 4

  15. Pain NRS score for dynamic brush allodynia (soft brush)

    Time frame: Weeks 2 and 4

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

    Time frame: Weeks 2 and 4

  17. Presence of metabonomic biomarkers

    Time frame: Weeks 1 and 4

  18. Physical examination

    Time frame: 1 week after 4-week treatment period

  19. Adverse events

    Time frame: Throughout study duration

  20. Clinical laboratory tests

    Time frame: 1 week after 4-week treatment period

  21. Subject assessed quality of pressure pain

    Time frame: Weeks 2 and 4

Sponsors and collaborators

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
May 8, 2008
Registry last updated
Feb 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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