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

Neuralgia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00674687
• Other study ID #: A9451138
• Status: Completed
• Phase: N/A
• Start date: July 2004
• Est. completion date: June 2006

Study information

• Verified date: May 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic

Intervention

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
• 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

Locations

Country	Name	City	State
United Kingdom	Pfizer Investigational Site	Liverpool

Sponsors (1)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS)		Weeks 2 and 4
Secondary	Subject assessed quality of evoked pain for punctate allodynia		Weeks 2 and 4
Secondary	Pain NRS score for temporal summation to dynamic brush allodynia (soft and coarse brush)		Weeks 2 and 4
Secondary	Pressure pain tolerance threshold		Weeks 2 and 4
Secondary	Pain NRS scores for pressure pain		Weeks 2 and 4
Secondary	Subject assessed quality of evoked pain for temporal summation to dynamic brush allodynia (soft and coarse brush)		Weeks 2 and 4
Secondary	Tactile threshold		Week 4
Secondary	Pressure pain detection threshold		Weeks 2 and 4
Secondary	Area of punctate and dynamic (soft and coarse brush) allodynia		Weeks 2 and 4
Secondary	Pain NRS score for punctate allodynia		Weeks 2 and 4
Secondary	Pain NRS scores for temporal summation to punctate stimuli		Weeks 2 and 4
Secondary	Subject assessed quality of evoked pain for temporal summation to punctate stimuli		Weeks 2 and 4
Secondary	Neuropathic pain scale		Week 4
Secondary	Test-day global pain scale		Week 4
Secondary	Pain diary card		Week 4
Secondary	Pain NRS score for dynamic brush allodynia (soft brush)		Weeks 2 and 4
Secondary	Subject assessed quality of evoked pain for dynamic brush allodynia (soft brush)		Weeks 2 and 4
Secondary	Presence of metabonomic biomarkers		Weeks 1 and 4
Secondary	Physical examination		1 week after 4-week treatment period
Secondary	Adverse events		Throughout study duration
Secondary	Clinical laboratory tests		1 week after 4-week treatment period
Secondary	Subject assessed quality of pressure pain		Weeks 2 and 4

External Links

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