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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00978341
Registration number
NCT00978341
Ethics application status
Date submitted
15/09/2009
Date registered
16/09/2009
Date last updated
25/01/2021
Titles & IDs
Public title
Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design
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Scientific title
A Methodology Study to Assess the Ability of a Randomised, Double Blind, Placebo Controlled, Crossover Trial Design in Spinal Cord Injury Patients With Pain of Neuropathic Origin to Detect Improvement in Pain Endpoints Using Pregabalin as a Benchmark Compound
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Secondary ID [1]
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A0081141
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injuries
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Condition category
Condition code
Injuries and Accidents
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Fractures
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Injuries and Accidents
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Other injuries and accidents
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pregabalin
Treatment: Drugs - Placebo for pregabalin
Experimental: Pregabalin -
Other: Placebo -
Treatment: Drugs: Pregabalin
Pregabalin 150mg capsules BID for 7.5 days
Treatment: Drugs: Placebo for pregabalin
Placebo capsules BID for 7.5 days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Present Pain Intensity Score
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Assessment method [1]
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Present pain intensity score: 0-10 numeric rating scale (NRS), 0 (no pain) to 10 (worst possible pain).
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Timepoint [1]
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Day 1: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours (post-dose); Day 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, and 48 hours (post-dose)
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Secondary outcome [1]
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Daily Pain Score
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Assessment method [1]
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Daily Pain Score: Day 1 pain intensity over past 24 hours recorded on waking every morning. 0-10 numeric rating scale (NRS): 0 (no pain) to 10 (worst possible pain).
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Timepoint [1]
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Predose: Daily from 7 days before Visit 2 (start of Intervention 1) until the morning of Visit 5 (end of Intervention 2)
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Secondary outcome [2]
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Dynamic Allodynia Area
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Assessment method [2]
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Area of dynamic allodynia was assessed using a brush (SENSElab Brush 05; velocity approximately 20 millimeters per second [mm/s]) by stimulating along a pattern of 8 radial spokes. Stimulation was started from the non-painful perimetry. Subjects were asked to report change in sensation from non-painful to painful and the spot was marked onto the skin. The area of dynamic allodynia was determined from these 8 distances by calculating the area of an octagon (in centimeter squared [cm2]).
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Timepoint [2]
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Screening, Days 1 & 8: 0 (pre-dose) & 4 hours post-dose,
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Secondary outcome [3]
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Dynamic Allodynia Pain Score
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Assessment method [3]
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Five strokes (each approx. 6 centimeters [cm] long) were applied with a standardized brush (SENSELab Brush 05) across the painful site (and a control site) at a constant velocity (20 millimeters per second [mm/sec]). Pain in response to brush stimulation of the allodynic area was recorded using an 11-point numeric rating scale from 0 (no pain) to 10 (worst possible pain). Patients were asked to give a pain rating after each brush stroke. A painful sensation was considered as representing brush allodynia.
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Timepoint [3]
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Screening, Days 1 & 8: 0 (pre-dose), 0.5, 1, 2, 3, 4, 5, and 6 hours post-dose
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Secondary outcome [4]
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Punctate Allodynia Area
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Assessment method [4]
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Area of punctate allodynia was determined using a von Frey filament (OptiHair2). Stimulation was started from the non-painful perimetry and repeated along a pattern of 8 radial spokes. With a movement along each spoke at steps of 5 millimeters (mm), the subjects reported sensation changes from non-painful to painful and the spot was marked on the skin. The area of punctate allodynia was determined from these 8 distances by calculating the area of an octagon (in square centimeter(s)[cm2]).
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Timepoint [4]
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Screening, Days 1 & 8: 0 (pre-dose) and 4 hours post-dose
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Secondary outcome [5]
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Mechanical Pain Sensitivity Stimulus-Response Function
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Assessment method [5]
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Mechanical pain sensitivity stimulus response function was assessed at the control and painful sites using calibrated von Frey monofilaments and the SENSElab brush. Seven different von Frey monofilaments (8 -512 milliNewtons [mN], force increases by a factor of two from filament to filament) and the brush were applied in a predetermined pseudo-random order. Pain rating for each stimulus: 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).
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Timepoint [5]
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Screening, Days 1 & 8: 0 (pre-dose), & 2, 4, and 6 hours post-dose
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Secondary outcome [6]
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Neuropathic Pain Symptom Inventory (NPSI)
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Assessment method [6]
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NPSI: subject rated questionnaire to evaluate 5 dimensions of neuropathic pain (dimensions: burning [superficial] spontaneous pain, pressing [deep] spontaneous pain, paroxysmal pain, evoked pain, and paresthesia/dyesthesia). Includes 10 descriptors ranging from 0 (no symptoms) to 10 (worst symptoms imaginable) and 2 temporal items assessing duration of spontaneous ongoing and paroxysmal pain. Questionnaire generates a score in each relevant dimension. Total score is calculated as the sum of scores of the 10 descriptors, range: 0-100. Higher score indicates greater intensity of pain.
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Timepoint [6]
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Prior to morning dosing on Day 1 and prior to discharge on Day 8 for each period.
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Secondary outcome [7]
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Pharmacokinetic Evaluations of Pregabalin
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Assessment method [7]
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Pharmacokinetic (PK) results are not presented in this report due to early termination of the trial. Pregabalin PK was not measured as there was incomplete data to conduct pharmacokinetic/pharmacodynamic analyses.
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Timepoint [7]
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Day 1: 0 (pre-dose), 0.5, 1, 2, and 6 hours post-dose; Day 8: 0 (pre-dose), 1, 4, & 6 hours post-dose
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Eligibility
Key inclusion criteria
- subjects who are outpatients or inpatients
- written informed consent obtained (signed by the subject or the subject's legally
acceptable representative)
- traumatic spinal cord injury of at least 1 year duration with a nonprogressive, i.e.,
chronic, stage of at least 6 months duration
- At-level neuropathic pain: spontaneous or evoked pain with neuropathic features
(sharp, shooting, electric or burning pain sensation) in the region of sensory
disturbance in a segmental pattern and located within two dermatomes above or below
the level of spinal cord injury
- Below-level neuropathic pain: spontaneous or evoked pain with neuropathic features
(sharp, shooting, electric or burning pain sensation) in the region of sensory
disturbance located at least three dermatomes below the level of spinal cord injury
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- spinal cord injury (subjects with central pain and musculoskeletal pain must be able
to make a distinction between the two)
- subjects who have previously not responded to 300 mg/day pregabalin: a non-responder
is defined as a subject who has a reduction in pain score of less than 30% from
baseline
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2008
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Sample size
Target
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Pfizer Investigational Site - Randwick
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Recruitment hospital [2]
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Pfizer Investigational Site - St Leonards
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Recruitment hospital [3]
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Pfizer Investigational Site - Warrawong
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Recruitment hospital [4]
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Pfizer Investigational Site - Heidelberg
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment postcode(s) [3]
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2502 - Warrawong
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The study is designed to assess if spinal cord injury patients have reduced pain after taking
either pregabalin or placebo in a cross over design. Patients had either pain at the level of
their injury or below the level of their injury.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00978341
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00978341
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