Clinical Trial: Trial of Efficacy and Safety of Pregabalin in Subjects with Neuropathic Pain Associated with Lumbo-Sacral Radiculopathy

This study is currently recruiting patients.
Verified by Pfizer September 2005

Sponsored by: Pfizer
Information provided by: Pfizer Identifier: NCT00159705


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
 Drug: pregabalin
Phase III

MedlinePlus related topics:  Peripheral Nerve Disorders

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Further Study Details: 
Primary Outcomes: Pain measurement
Expected Total Enrollment:  200

Study start: April 2005


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

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.

Location and Contact Information

Please refer to this study by identifier  NCT00159705

Pfizer 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

      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

      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

      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

      Pfizer Investigational Site, Badalona,  BARCELONA,  08916,  Spain; Recruiting

Study chairs or principal investigators

Pfizer Call Center,  Study Director,  Pfizer   

More Information

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


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