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

Condition	Intervention	Phase
Radiculopathy	Drug: pregabalin	Phase III

Further Study Details: 

Primary Outcomes: Pain measurement
Expected Total Enrollment:  200

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

Please refer to this study by ClinicalTrials.gov identifier  NCT00159705

Pfizer CT.gov Call Center      1-800-718-1021 

New York
      Pfizer Investigational Site, Rochester,  New York,  14621,  United States; Recruiting
      Pfizer Investigational Site, Valley Stream,  New York,  11580,  United States; Recruiting
Pennsylvania
      Pfizer Investigational Site, Allentown,  Pennsylvania,  18013,  United States; Recruiting
      Pfizer Investigational Site, Allentown,  Pennsylvania,  18103,  United States; Recruiting
      Pfizer Investigational Site, Bethlehem,  Pennsylvania,  18017,  United States; Recruiting
Belgium
      Pfizer Investigational Site, Edegem,  B-2650,  Belgium; Recruiting
      Pfizer Investigational Site, Pellenberg,  B-3212,  Belgium; Recruiting
Canada, Ontario
      Pfizer Investigational Site, London,  Ontario,  N6A 4V2,  Canada; Recruiting
      Pfizer Investigational Site, Toronto,  Ontario,  M9W 4L6,  Canada; Recruiting
      Pfizer Investigational Site, Hawkesbury,  Ontario,  K6A 1A1,  Canada; Recruiting
Italy, Pavia
      Pfizer Investigational Site, Localita'''' Cravino,  Pavia,  27100,  Italy; Recruiting
Spain
      Pfizer Investigational Site, Granada,  18014,  Spain; Recruiting
      Pfizer Investigational Site, Madrid,  28006,  Spain; Recruiting
      Pfizer Investigational Site, Sevilla,  41071,  Spain; Recruiting
      Pfizer Investigational Site, Sevilla,  41013,  Spain; Recruiting
      Pfizer Investigational Site, Valencia,  46014,  Spain; Recruiting
Spain, BARCELONA
      Pfizer Investigational Site, Badalona,  BARCELONA,  08916,  Spain; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A0081007
Last Updated:  September 11, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00159705
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13