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NCT00159705 Clinical Trial

Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy

Radiculopathy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00159705
Other study ID # A0081007
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date April 2005
Est. completion date June 2007

Study information
Verified date October 2008
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy.

Recruitment information / eligibility
Status Completed
Enrollment 276
Est. completion date June 2007
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Criteria: - 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• pregabalin

Locations
Country Name City State
Belgium Pfizer Investigational Site Edegem
Belgium Pfizer Investigational Site Eeklo
Belgium Pfizer Investigational Site Genk
Belgium Pfizer Investigational Site Pellenberg
Canada Pfizer Investigational Site Fleurimont Quebec
Canada Pfizer Investigational Site Hawkesbury Ontario
Canada Pfizer Investigational Site Kingston Ontario
Canada Pfizer Investigational Site London Ontario
Canada Pfizer Investigational Site Montreal Quebec
Canada Pfizer Investigational Site Toronto Ontario
Canada Pfizer Investigational Site Vancouver British Columbia
Germany Pfizer Investigational Site Bremen
Germany Pfizer Investigational Site Eichstaett
Germany Pfizer Investigational Site Goeppingen
Germany Pfizer Investigational Site Kiel
Germany Pfizer Investigational Site Muenchen
Germany Pfizer Investigational Site Nuernberg
Germany Pfizer Investigational Site Wiesbaden
Italy Pfizer Investigational Site Imperia
Italy Pfizer Investigational Site Localita' Cravino Pavia
Italy Pfizer Investigational Site Milano
Italy Pfizer Investigational Site Napoli
Italy Pfizer Investigational Site Pavia
Italy Pfizer Investigational Site Roma
Spain Pfizer Investigational Site Badalona Barcelona
Spain Pfizer Investigational Site Granada
Spain Pfizer Investigational Site Madrid
Spain Pfizer Investigational Site Sevilla
Spain Pfizer Investigational Site Sevilla
Spain Pfizer Investigational Site Valencia
Sweden Pfizer Investigational Site Goteborg
Sweden Pfizer Investigational Site Lidingo
Sweden Pfizer Investigational Site Linkoping
Sweden Pfizer Investigational Site Lulea
Sweden Pfizer Investigational Site Skelleftea
Sweden Pfizer Investigational Site Stockholm
Turkey Pfizer Investigational Site Ankara
Turkey Pfizer Investigational Site Inciralti Izmir
Turkey Pfizer Investigational Site Istanbul
United States Pfizer Investigational Site Allentown Pennsylvania
United States Pfizer Investigational Site Allentown Pennsylvania
United States Pfizer Investigational Site Bethlehem Pennsylvania
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Denver Colorado
United States Pfizer Investigational Site Independence Missouri
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Phoenix Arizona
United States Pfizer Investigational Site Plantation Florida
United States Pfizer Investigational Site Portland Oregon
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Valley Stream New York

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Italy,  Spain,  Sweden,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain measurement
See also
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Terminated NCT01850771 - Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy N/A
Completed NCT02130258 - Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome N/A
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