A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury

NCT00407745

Last updated date
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85016, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Neuralgia, Spinal Cord Injuries
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

- Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas)

- Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months

- Pain score at least 4 in 4 of 7 days prior to receive treatment.

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


- Pregabalin use in the last 60 days, prior intolerance to pregabalin


- Creatinine clearance <60 mL/min.


- White blood cell count <2500/mm3; neutrophil count <1500/mm3; platelet count <100 x
103/ mm3.


- Abuse of drugs or alcohol


- Unstable medial conditions


- Clinically significant abnormal electrocardiogram (ECG).


- Presence of severe pain associated with conditions other than spinal cord injury that
could confound the assessment or self-evaluation of pain due to spinal cord injury.

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Neuralgia, Spinal Cord InjuriesA 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury
NCT00407745
  1. Phoenix, Arizona
  2. Phoenix, Arizona
  3. Phoenix, Arizona
  4. Fresno, California
  5. Napa, California
  6. Northridge, California
  7. Pasadena, California
  8. Miami, Florida
  9. Miami, Florida
  10. Orlando, Florida
  11. Indianapolis, Indiana
  12. Overland Park, Kansas
  13. Detroit, Michigan
  14. New York, New York
  15. White Plains, New York
  16. Winston-Salem, North Carolina
  17. Bellevue, Ohio
  18. Johnstown, Pennsylvania
  19. Philadelphia, Pennsylvania
  20. Dallas, Texas
  21. Charleston, West Virginia
  22. Charleston, West Virginia
  23. Vina del Mar, V Region
  24. Beijing, Beijing
  25. Chengdu, Sichuan
  26. Beijing,
  27. Medellín, Antioquia
  28. Brno,
  29. Liberec 1,
  30. Praha 5,
  31. Hong Kong,
  32. Secunderabad, Andhra Pradesh
  33. Bangalore, Karnataka
  34. Bangalore, Karnataka
  35. Mangalore, Karnataka
  36. Lucknow, Uttar Pradesh
  37. New Delhi,
  38. Nagoya, Aichi
  39. Daisen, Akita
  40. Iizuka, Fukuoka
  41. Fukuyama, Hiroshima
  42. Bibai, Hokkaido
  43. Hakodate, Hokkaido
  44. Sapporo, Hokkaido
  45. Kobe, Hyogo
  46. Sasima-gun, Ibaraki
  47. Kawasaki, Kanagawa
  48. Kikuchi-gun, Kumamoto
  49. Sendai, Miyagi
  50. Kashiwazaki, Niigata
  51. Beppu, Oita
  52. Hanyu, Saitama
  53. Kitamoto, Saitama
  54. Hamamatsu, Shizuoka
  55. Kanuma, Tochigi
  56. Kotoku, Tokyo
  57. Musashimurayama-shi, Tokyo
  58. Higashiokitama-gun, Yamagata
  59. Chiba,
  60. Tokushima,
  61. Yamagata,
  62. Espana, Manila
  63. Cebu City,
  64. Manila,
  65. Quezon City,
  66. Moscow,
  67. St.Petersburg,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury
Official Title  ICMJE A 17-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Trial Of Pregabalin For The Treatment Of Chronic Central Neuropathic Pain After Spinal Cord Injury
Brief Summary The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). This study will also evaluate the safety of pregabalin in this patient population.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Neuralgia
  • Spinal Cord Injuries
Intervention  ICMJE
  • Drug: placebo
    Placebo
  • Drug: pregabalin
    Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)
    Other Name: Lyrica
Study Arms  ICMJE
  • Placebo Comparator: matched placebo
    Intervention: Drug: placebo
  • Experimental: pregabalin
    flexible dosing over 4 weeks followed by 12 weeks maintenance and one week taper period
    Intervention: Drug: pregabalin
Publications *

*   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: March 31, 2011)
220
Original Enrollment  ICMJE
 (submitted: December 4, 2006)
300
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas)
  • Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months
  • Pain score at least 4 in 4 of 7 days prior to receive treatment.

Exclusion Criteria:

  • Pregabalin use in the last 60 days, prior intolerance to pregabalin
  • Creatinine clearance <60 mL/min.
  • White blood cell count <2500/mm3; neutrophil count <1500/mm3; platelet count <100 x 103/ mm3.
  • Abuse of drugs or alcohol
  • Unstable medial conditions
  • Clinically significant abnormal electrocardiogram (ECG).
  • Presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.
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 Chile,   China,   Colombia,   Czech Republic,   Hong Kong,   India,   Japan,   Philippines,   Russian Federation,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00407745
Other Study ID Numbers  ICMJE A0081107
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2012

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