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

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NCT00159705

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Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85023, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Radiculopathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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RadiculopathyTrial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy
NCT00159705
  1. Phoenix, Arizona
  2. Denver, Colorado
  3. Plantation, Florida
  4. Chicago, Illinois
  5. Indianapolis, Indiana
  6. Boston, Massachusetts
  7. Independence, Missouri
  8. Rochester, New York
  9. Valley Stream, New York
  10. Portland, Oregon
  11. Allentown, Pennsylvania
  12. Allentown, Pennsylvania
  13. Bethlehem, Pennsylvania
  14. Edegem,
  15. Eeklo,
  16. Genk,
  17. Pellenberg,
  18. Vancouver, British Columbia
  19. Hawkesbury, Ontario
  20. Kingston, Ontario
  21. London, Ontario
  22. Toronto, Ontario
  23. Fleurimont, Quebec
  24. Montreal, Quebec
  25. Bremen,
  26. Eichstaett,
  27. Goeppingen,
  28. Kiel,
  29. Muenchen,
  30. Nuernberg,
  31. Wiesbaden,
  32. Localita' Cravino, Pavia
  33. Imperia,
  34. Milano,
  35. Napoli,
  36. Pavia,
  37. Roma,
  38. Badalona, Barcelona
  39. Granada,
  40. Madrid,
  41. Sevilla,
  42. Sevilla,
  43. Valencia,
  44. Goteborg,
  45. Lidingo,
  46. Linkoping,
  47. Lulea,
  48. Skelleftea,
  49. Stockholm,
  50. Inciralti, Izmir
  51. Ankara,
  52. Istanbul,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Trial of Efficacy and Safety of Pregabalin in Subjects With Neuropathic Pain Associated With Lumbo-Sacral Radiculopathy
Official Title  ICMJE 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
Brief Summary Trial will evaluate the efficacy and safety of pregabalin in the treatment of subjects with neuropathic pain associated with lumbo-sacral radiculopathy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Radiculopathy
Intervention  ICMJE Drug: pregabalin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2008)		276
Original Enrollment  ICMJE
 (submitted: September 8, 2005)		200
Actual Study Completion Date  ICMJE June 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Germany,   Italy,   Spain,   Sweden,   Turkey,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00159705
Other Study ID Numbers  ICMJE A0081007
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP