Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy
A Randomized Placebo-Controlled Trial of the Efficacy and Safety of Pregabalin in the Treatment of Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy
1 other identifier
interventional
276
8 countries
52
Brief Summary
Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2005
52 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedJanuary 25, 2021
October 1, 2008
September 8, 2005
January 21, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pain measurement
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
Pfizer Investigational Site
Phoenix, Arizona, 85023, United States
Pfizer Investigational Site
Denver, Colorado, 80218, United States
Pfizer Investigational Site
Plantation, Florida, 33324, United States
Pfizer Investigational Site
Chicago, Illinois, 60612, United States
Pfizer Investigational Site
Indianapolis, Indiana, 46250, United States
Pfizer Investigational Site
Boston, Massachusetts, 02115, United States
Pfizer Investigational Site
Independence, Missouri, 64055, United States
Pfizer Investigational Site
Rochester, New York, 14621, United States
Pfizer Investigational Site
Valley Stream, New York, 11580, United States
Pfizer Investigational Site
Portland, Oregon, 97239, United States
Pfizer Investigational Site
Allentown, Pennsylvania, 18013, United States
Pfizer Investigational Site
Allentown, Pennsylvania, 18103, United States
Pfizer Investigational Site
Bethlehem, Pennsylvania, 18017, United States
Pfizer Investigational Site
Edegem, B-2650, Belgium
Pfizer Investigational Site
Eeklo, B-9900, Belgium
Pfizer Investigational Site
Genk, B-3600, Belgium
Pfizer Investigational Site
Pellenberg, B-3212, Belgium
Pfizer Investigational Site
Vancouver, British Columbia, V6Z 2E8, Canada
Pfizer Investigational Site
Hawkesbury, Ontario, K6A 1A1, Canada
Pfizer Investigational Site
Kingston, Ontario, K7L 2V7, Canada
Pfizer Investigational Site
London, Ontario, N6A 4V2, Canada
Pfizer Investigational Site
Toronto, Ontario, M9W 4L6, Canada
Pfizer Investigational Site
Fleurimont, Quebec, J1H 5N4, Canada
Pfizer Investigational Site
Montreal, Quebec, H3A 2B4, Canada
Pfizer Investigational Site
Bremen, 28329, Germany
Pfizer Investigational Site
Eichstätt, 85072, Germany
Pfizer Investigational Site
Göppingen, 73033, Germany
Pfizer Investigational Site
Kiel, 24105, Germany
Pfizer Investigational Site
München, 81675, Germany
Pfizer Investigational Site
Nuremberg, 90489, Germany
Pfizer Investigational Site
Wiesbaden, 65189, Germany
Pfizer Investigational Site
Localita' Cravino, Pavia, 27100, Italy
Pfizer Investigational Site
Imperia, 18100, Italy
Pfizer Investigational Site
Milan, 20100, Italy
Pfizer Investigational Site
Napoli, 80126, Italy
Pfizer Investigational Site
Pavia, 27100, Italy
Pfizer Investigational Site
Roma, 00168, Italy
Pfizer Investigational Site
Badalona, Barcelona, 08916, Spain
Pfizer Investigational Site
Granada, 18014, Spain
Pfizer Investigational Site
Madrid, 28006, Spain
Pfizer Investigational Site
Seville, 41013, Spain
Pfizer Investigational Site
Seville, 41071, Spain
Pfizer Investigational Site
Valencia, 46014, Spain
Pfizer Investigational Site
Gothenburg, 400 10, Sweden
Pfizer Investigational Site
Lidingö, 181 39, Sweden
Pfizer Investigational Site
Linköping, 581 85, Sweden
Pfizer Investigational Site
Luleå, 972 33, Sweden
Pfizer Investigational Site
Skellefteå, 931 87, Sweden
Pfizer Investigational Site
Stockholm, 182 88, Sweden
Pfizer Investigational Site
Inciraltı, İzmir, 35340, Turkey (Türkiye)
Pfizer Investigational Site
Ankara, 06100, Turkey (Türkiye)
Pfizer Investigational Site
Istanbul, 34390, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
April 1, 2005
Study Completion
June 1, 2007
Last Updated
January 25, 2021
Record last verified: 2008-10