Back to resultsA Study Of The Efficacy Of Gabapentin In Neuropathic Pain Patients As Measured By Quantitative Sensory Testing
Primary Purpose
Neuralgia, Neuralgia, Postherpetic
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
2-weeks placebo then gabapentin
1-week placebo then gabapentin
Sponsored by
About this trial
This is an interventional treatment trial for Neuralgia
Eligibility 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
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Sequence 1
Sequence 2
Arm Description
Outcomes
Primary Outcome Measures
Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS)
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00674687
First Posted
May 6, 2008
Last Updated
February 1, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00674687
Brief Title
A Study Of The Efficacy Of Gabapentin In Neuropathic Pain Patients As Measured By Quantitative Sensory Testing
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 Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Neuralgia, Postherpetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence 1
Arm Type
Placebo Comparator
Arm Title
Sequence 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
2-weeks placebo then gabapentin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
1-week placebo then gabapentin
Intervention Description
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 Outcome Measure Information:
Title
Presence/intensity of punctate allodynia (von Frey filament), measured on the pain numeric rating scale (NRS)
Time Frame
Weeks 2 and 4
Secondary Outcome Measure Information:
Title
Subject assessed quality of evoked pain for punctate allodynia
Time Frame
Weeks 2 and 4
Title
Pain NRS score for temporal summation to dynamic brush allodynia (soft and coarse brush)
Time Frame
Weeks 2 and 4
Title
Pressure pain tolerance threshold
Time Frame
Weeks 2 and 4
Title
Pain NRS scores for pressure pain
Time Frame
Weeks 2 and 4
Title
Subject assessed quality of evoked pain for temporal summation to dynamic brush allodynia (soft and coarse brush)
Time Frame
Weeks 2 and 4
Title
Tactile threshold
Time Frame
Week 4
Title
Pressure pain detection threshold
Time Frame
Weeks 2 and 4
Title
Area of punctate and dynamic (soft and coarse brush) allodynia
Time Frame
Weeks 2 and 4
Title
Pain NRS score for punctate allodynia
Time Frame
Weeks 2 and 4
Title
Pain NRS scores for temporal summation to punctate stimuli
Time Frame
Weeks 2 and 4
Title
Subject assessed quality of evoked pain for temporal summation to punctate stimuli
Time Frame
Weeks 2 and 4
Title
Neuropathic pain scale
Time Frame
Week 4
Title
Test-day global pain scale
Time Frame
Week 4
Title
Pain diary card
Time Frame
Week 4
Title
Pain NRS score for dynamic brush allodynia (soft brush)
Time Frame
Weeks 2 and 4
Title
Subject assessed quality of evoked pain for dynamic brush allodynia (soft brush)
Time Frame
Weeks 2 and 4
Title
Presence of metabonomic biomarkers
Time Frame
Weeks 1 and 4
Title
Physical examination
Time Frame
1 week after 4-week treatment period
Title
Adverse events
Time Frame
Throughout study duration
Title
Clinical laboratory tests
Time Frame
1 week after 4-week treatment period
Title
Subject assessed quality of pressure pain
Time Frame
Weeks 2 and 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9451138&StudyName=A%20Study%20Of%20The%20Efficacy%20Of%20Gabapentin%20In%20Neuropathic%20Pain%20Patients%20As%20Measured%20By%20Quantitative%20Sensory%20Testing
Description
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Learn more about this trial
A Study Of The Efficacy Of Gabapentin In Neuropathic Pain Patients As Measured By Quantitative Sensory Testing
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