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

NCT00674687 | Completed

• 1 other identifier: A9451138
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuralgia; Neuralgia, Postherpetic

Outcome Measures

Primary Outcomes (1)

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

  Weeks 2 and 4

Secondary Outcomes (21)

• Subject assessed quality of evoked pain for punctate allodynia

  Weeks 2 and 4

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

  Weeks 2 and 4

• Pressure pain tolerance threshold

  Weeks 2 and 4

• Pain NRS scores for pressure pain

  Weeks 2 and 4

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

  Weeks 2 and 4

Study Arms (2)

Sequence 1

PLACEBO COMPARATOR

Drug: 2-weeks placebo then gabapentin

Sequence 2

EXPERIMENTAL

Drug: 1-week placebo then gabapentin

Interventions

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

Sequence 1

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

Sequence 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Pfizer Investigational Site

Liverpool, L9 7AL, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Neuralgia; Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 8, 2008
• Study Start: July 1, 2004
• Study Completion: June 1, 2006
• Last Updated: February 2, 2021

Record last verified: 2008-05

Locations

GB (1)