Back to resultsStudy To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain
Primary Purpose
Neuropathic Pain
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Pregabalin
Placebo
Sponsored by
About this trial
This is an interventional other trial for Neuropathic Pain focused on measuring Methodology, Quantitative Sensory Testing, Neuropathies Pain, Pregabalin
Eligibility Criteria
Inclusion Criteria:
- Neuropathic pain of peripheral origin demonstrating spontaneous ongoing pain and dynamic mechanical allodynia to brush stimuli.
- A present pain intensity score of 4 or more (out of 10) for spontaneous ongoing pain and brush-evoked allodynia at the skin area at screen.
- Stable analgesic medication (excluding pregabalin) for a minimum of 1 month prior to the start of study.
Exclusion Criteria:
- Patients who have undergone neurolytic or neurosurgical therapy.
- Patients who have trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and traumatic spinal cord injuries), complex regional pain syndrome (Type I and II), and phantom limb pain.
- Patients who have previously been treated with pregabalin.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active drug
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7
Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a "strange" or "tickly" sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score.
Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7
Dynamic area brush in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score.
Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Punctate allodynia area in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)
Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.
Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.
Secondary Outcome Measures
Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7
Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline).
Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7
PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse.
Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7
Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to "How intense is your pain today?"
Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7
NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01117766
Brief Title
Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain
Official Title
A Randomized, Double Blind, Placebo Controlled, 2-Way Crossover Methodology Study Designed To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing (QST) In Patients With Neuropathic Pain Treated With Pregabalin Vs Placebo
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
5. Study Description
Brief Summary
Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to detect treatment efficacy in small-scale clinical trials. Combining conventional pain efficacy measures with quantitative sensory testing (QST) may provide more sensitive and informative outcome measures in clinical trials.
Detailed Description
Methodology to assess reproducibility and sensitivity of quantitative sensory testing
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Methodology, Quantitative Sensory Testing, Neuropathies Pain, Pregabalin
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active drug
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pregabalin
Intervention Description
Dose titration according to following regimen: 75mg BID for 3 days; 150mg for 4 days; 225mg BID for 4 days; 300mg BID for 17 days. Dose reduced for renally impaired patients
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
BID dosing for 28 days
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Dynamic Allodynia Intensity at Visits 3 and 6 and Visits 4 and 7
Description
Five strokes applied with a standardized brush (somedic) across the painful site, 6cm long and at a control site to allow the participants to appreciate any difference. A painful and clearly dysaesthetic (unpleasant) sensation was considered as representing brush allodynia (whereas a "strange" or "tickly" sensation provoked by the brush was not). After each brush stimuli participants were asked to give a pain rating using 11-point numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable. The average of 5 brush strokes was calculated to obtain the mean score.
Time Frame
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Title
Mean Change From Baseline in Dynamic Allodynia Area at Visits 3 and 6 and Visits 4 and 7
Description
Dynamic area brush in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)
Time Frame
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Title
Mean Change From Baseline in Mechanical Pain Sensitivity (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Description
Sensitivity to mechanical pain stimuli was tested using calibrated Von Frey monofilaments. To obtain a stimulus-response-function, seven different Von Frey monofilaments (size 8 to 512 mN, force increased by a factor of two from filament to filament) applied three times each; each stimulus was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. If a score of 8 or more was reported for a given intensity no stronger stimuli was applied. Von Frey stimulus was applied to the skin for 1 to 2 seconds. The average of 3 ratings was calculated for the mean score.
Time Frame
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Title
Mean Change From Baseline in Punctate Allodynia Area (Von Frey) at Visits 3 and 6 and Visits 4 and 7
Description
Punctate allodynia area in cm^2: calculated from 8 measured distances by calculating the area of an octagon. The angle between each pair of lines was 45 degrees at point c. The area of the octagon was found by totaling the areas of the 8 triangles. Octagon with 8 radial lengths from center to the outside. Area = Σ ( ½ length * perpendicular height); Σ ( ½ ri * sin(45) r(i+1) ) = Σ ( (ri * r(i+1) )/2√2)). (where ri, i=1 to 8, were the eight radial lengths)
Time Frame
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Title
Mean Change From Baseline in Cold Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Description
Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 5 degrees celsius for cold stimuli (between 5 and 20 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.
Time Frame
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Title
Mean Change From Baseline in Heat Pain Sensitivity at Visits 3 and 6 and Visits 4 and 7
Description
Duration of thermal stimuli was 2 seconds and an intensity that is increased in steps of 4 degrees celsius for heat stimuli (between 40 and 50 degrees celsius). Thermal pain sensitivity was participant-rated using 11-point NRS where 0=no pain and 10=worst pain imaginable. The average of 2 ratings was calculated to get the mean score.
Time Frame
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Weekly Pain Score From the Daily Diary at Visits 3 and 6 and Visits 4 and 7
Description
Daily pain diary: participant-rated pain during the past 24 hours rated on an 11 point NRS scale where 0=no pain and 10=worst possible pain. For a given week, the pain response was the average of the 7 daily entries for that week, or average of the available data for that week if fewer than 7 entries were recorded (>=1 daily pain score for any given week required). The endpoint for each week consisted of the change from baseline in average pain score (follow-up value minus baseline).
Time Frame
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Title
Mean Change From Baseline in Patient's Global Impression of Change (PGIC) at Visits 3 and 6 and Visits 4 and 7
Description
PGIC: participant-rated assessment measuring change in participant's overall status on a 7-point scale from 1=very much improved to 7=very much worse.
Time Frame
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Title
Mean Change From Baseline in Test-Day Global Pain Intensity at Visits 3 and 6 and Visits 4 and 7
Description
Global pain: participant-rated pain using the test-day global pain scale, consisting of an 11-point NRS where 0 = no pain and 10 = worst possible pain. Participants described intensity of pain in response to "How intense is your pain today?"
Time Frame
Week 3 (Visits 3 and 6) and Week 4 (Visits 4 and 7) of each period
Title
Mean Change From Baseline in Neuropathic Pain Symptom Inventory (NPSI) Total Score at Visits 4 and 7
Description
NPSI: 10-item self-administered questionnaire assessing 5 dimensions of pain (burning superficial spontaneous pain, pressing deep spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dysesthesia). Each item consists of a question about the specific qualities of pain and an 11-point numerical scale range: 0 (absence of pain) to 10 (maximum intensity imaginable), and 2 temporal items related to spontaneous and paroxysmal pain. Maximum total score possible = 100.
Time Frame
Week 4 (Visits 4 and 7) of each period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Neuropathic pain of peripheral origin demonstrating spontaneous ongoing pain and dynamic mechanical allodynia to brush stimuli.
A present pain intensity score of 4 or more (out of 10) for spontaneous ongoing pain and brush-evoked allodynia at the skin area at screen.
Stable analgesic medication (excluding pregabalin) for a minimum of 1 month prior to the start of study.
Exclusion Criteria:
Patients who have undergone neurolytic or neurosurgical therapy.
Patients who have trigeminal neuralgia, central pain (due to cerebrovascular lesions, multiple sclerosis and traumatic spinal cord injuries), complex regional pain syndrome (Type I and II), and phantom limb pain.
Patients who have previously been treated with pregabalin.
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
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Boulogne Billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Pfizer Investigational Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A9011015&StudyName=Study%20To%20Assess%20The%20Reproducibility%20And%20Sensitivity%20Of%20Quantitative%20Sensory%20Testing%20In%20Patients%20With%20Neuropathic%20Pain%20
Description
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Study To Assess The Reproducibility And Sensitivity Of Quantitative Sensory Testing In Patients With Neuropathic Pain
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