Status:
COMPLETED
A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Neuralgia
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate...
Eligibility Criteria
Inclusion
- Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas)
- Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months
- Pain score at least 4 in 4 of 7 days prior to receive treatment.
Exclusion
- Pregabalin use in the last 60 days, prior intolerance to pregabalin
- Creatinine clearance \<60 mL/min.
- White blood cell count \<2500/mm3; neutrophil count \<1500/mm3; platelet count \<100 x 103/ mm3.
- Abuse of drugs or alcohol
- Unstable medial conditions
- Clinically significant abnormal electrocardiogram (ECG).
- Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00407745
Start Date
January 1 2007
End Date
February 1 2011
Last Update
January 25 2021
Active Locations (67)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85016
2
Pfizer Investigational Site
Phoenix, Arizona, United States, 85027
3
Pfizer Investigational Site
Phoenix, Arizona, United States, 85050
4
Pfizer Investigational Site
Fresno, California, United States, 93710