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Study to Determine if a Reduction in Pain Can be Measured in Spinal Cord Injured Patients Using a New Study Design

Last updated on March 15, 2019

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Study Location
Pfizer Investigational Site
Randwick, New South Wales, 2031 Australia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Spinal Cord Injuries
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00978341
Pfizer
Terminated
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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