Clinical trial NCT00159705: Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Radiculopathy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Pain measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: Denver
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Plantation
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Independence
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Valley Stream
country: United States
facility: Pfizer Investigational Site
state: New York
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Allentown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Bethlehem
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Edegem
country: Belgium
facility: Pfizer Investigational Site
city: Eeklo
country: Belgium
facility: Pfizer Investigational Site
city: Genk
country: Belgium
facility: Pfizer Investigational Site
city: Pellenberg
country: Belgium
facility: Pfizer Investigational Site
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Hawkesbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Fleurimont
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Bremen
country: Germany
facility: Pfizer Investigational Site
city: Eichstaett
country: Germany
facility: Pfizer Investigational Site
city: Goeppingen
country: Germany
facility: Pfizer Investigational Site
city: Kiel
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Nuernberg
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: Localita' Cravino
country: Italy
facility: Pfizer Investigational Site
state: Pavia
city: Imperia
country: Italy
facility: Pfizer Investigational Site
city: Milano
country: Italy
facility: Pfizer Investigational Site
city: Napoli
country: Italy
facility: Pfizer Investigational Site
city: Pavia
country: Italy
facility: Pfizer Investigational Site
city: Roma
country: Italy
facility: Pfizer Investigational Site
city: Badalona
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Granada
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Sevilla
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Lidingo
country: Sweden
facility: Pfizer Investigational Site
city: Linkoping
country: Sweden
facility: Pfizer Investigational Site
city: Lulea
country: Sweden
facility: Pfizer Investigational Site
city: Skelleftea
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Inciralti
country: Turkey
facility: Pfizer Investigational Site
state: Izmir
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: