Status:
COMPLETED
Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy
Lead Sponsor:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Conditions:
Radiculopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy.
Eligibility Criteria
Inclusion
- Pain consistent with a diagnosis of chronic lumbo-sacral radiculopathy due to spinal stenosis or disk herniation.
- Radicular pain must be present for at least 3 months and pain stable for at least 4 weeks.
Exclusion
- Surgery for lumbo-sacral radiculopathy within previous 6 months and/or more than one previous spinal surgery for pain-radiculopathy.
- Epidural injection for lumbo-sacral radiculopathy within previous 6 weeks and/or anticipated need for treatment with opioid analgesics, anti-epileptic medications or tricyclic antidepressants to alleviate pain due to lumbo-sacral radiculopathy during the course of the study.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT00159705
Start Date
April 1 2005
End Date
June 1 2007
Last Update
January 25 2021
Active Locations (52)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85023
2
Pfizer Investigational Site
Denver, Colorado, United States, 80218
3
Pfizer Investigational Site
Plantation, Florida, United States, 33324
4
Pfizer Investigational Site
Chicago, Illinois, United States, 60612