Status:
TERMINATED
Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18-70 years
Phase:
NA
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...
Detailed Description
This methodology study was terminated on October 13, 2008 based on interim results for an exploratory, novel endpoint. The results of the primary analysis at the interim for N=12 patients showed resul...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00978341
Start Date
February 1 2007
End Date
October 1 2008
Last Update
January 25 2021
Active Locations (4)
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1
Pfizer Investigational Site
Randwick, New South Wales, Australia, 2031
2
Pfizer Investigational Site
St Leonards, New South Wales, Australia, 2065
3
Pfizer Investigational Site
Warrawong, New South Wales, Australia, 2502
4
Pfizer Investigational Site
Heidelberg, Victoria, Australia, 3084