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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

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NCT00978341

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Randwick, New South Wales, 2031 Australia
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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.
Show details

- 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.
Show details

- 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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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
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.
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 results that generally favored pregabalin but were not statistically significant compared to placebo. Based on the estimated conditional power, this result is unlikely to change with full recruitment of N=24 patients and therefore the data monitoring committee recommended termination of the trial. The decision to terminate the trial was not based on any safety concerns.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Spinal Cord Injuries
  • Drug: Pregabalin
    Pregabalin 150mg capsules BID for 7.5 days
  • Drug: Placebo for pregabalin
    Placebo capsules BID for 7.5 days
  • Experimental: Pregabalin
    Intervention: Drug: Pregabalin
  • Placebo
    Intervention: Drug: Placebo for pregabalin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
October 2008
October 2008   (Final data collection date for primary outcome measure)

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

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT00978341
A0081141
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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