An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain

NCT01202227

Last updated date
Study Location
Chubu Rosai Hospital
Nagoya, Aichi, , Japan
Contact
1-800-718-1021

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

Inclusion criteria for subjects to be shifted from Study A0081107

- Subjects who completed the 18-week study period in Study A0081107 conducted for chronic neuropathic pain after spinal cord injury;

- Subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding Study A0081107 (V7);

Inclusion criteria for subjects to be new participants in this study

- Subjects with central neuropathic pain after stroke or multiple sclerosis;

- At least 6 months have passed after the onset of central neuropathic pain;

- Pain VAS at least 40mm in Visit 1 and Visit 2;

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


- Creatinine clearance < 60 mL/min;


- Platelet count < 100 × 103/mm3 ; White blood cell (WBC) count < 2500 / mm3; Neutrophil
count < 1500/ mm3;


- Subjects who are expected to require surgery during the trial;

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Spinal Cord Diseases, Spinal Cord Injuries, Neuralgia, PainAn Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
NCT01202227
  1. Nagoya, Aichi
  2. Nagoya, Aichi
  3. Nagoya, Aichi
  4. Daisen, Akita
  5. Chikushi-gun, Fukuoka
  6. Iizuka, Fukuoka
  7. Fukuyama, Hiroshima
  8. Bibai, Hokkaido
  9. Hakodate, Hokkaido
  10. Kobe, Hyogo
  11. Moriya, Ibaraki
  12. Hanamaki, Iwate
  13. Kawasaki, Kanagawa
  14. Kikuchi-gun, Kumamoto
  15. Sendai-city, Miyagi
  16. Sendai, Miyagi
  17. Kashiwazaki, Niigata
  18. Beppu, Oita
  19. Kitamoto, Saitama
  20. Kanuma, Tochigi
  21. Bunkyo-ku, Tokyo
  22. Koto-ku, Tokyo
  23. Musashimurayama-shi, Tokyo
  24. Higashiokitama-gun, Yamagata
  25. Tokushima,
  26. Yamagata,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
Official Title  ICMJE An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain (Post Spinal Cord Injury Pain, Post Stroke Pain, And Multiple Sclerosis Pain)
Brief Summary The purpose of this study is to assess the safety of the long-term use of pregabalin at doses up to 600 mg/day in patients with central neuropathic pain (post spinal cord injury pain, post stroke pain, and multiple sclerosis pain).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Diseases
  • Spinal Cord Injuries
  • Neuralgia
  • Pain
Intervention  ICMJE Drug: pregabalin
Pregabalin capsules taken twice a daily (150-600mg/day)
Study Arms  ICMJE Experimental: Pregabalin
Flexible dosing in 4 weeks followed by 48 weeks maintenance and one week taper period
Intervention: Drug: pregabalin
Publications * Onouchi K, Koga H, Yokoyama K, Yoshiyama T. An open-label, long-term study examining the safety and tolerability of pregabalin in Japanese patients with central neuropathic pain. J Pain Res. 2014 Jul 28;7:439-47. doi: 10.2147/JPR.S63028. eCollection 2014.

*   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: April 17, 2012)
104
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2010)
100
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Inclusion criteria for subjects to be shifted from Study A0081107

  • Subjects who completed the 18-week study period in Study A0081107 conducted for chronic neuropathic pain after spinal cord injury;
  • Subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding Study A0081107 (V7);

Inclusion criteria for subjects to be new participants in this study

  • Subjects with central neuropathic pain after stroke or multiple sclerosis;
  • At least 6 months have passed after the onset of central neuropathic pain;
  • Pain VAS at least 40mm in Visit 1 and Visit 2;

Exclusion Criteria:

  • Creatinine clearance < 60 mL/min;
  • Platelet count < 100 × 103/mm3 ; White blood cell (WBC) count < 2500 / mm3; Neutrophil count < 1500/ mm3;
  • Subjects who are expected to require surgery during the trial;
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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01202227
Other Study ID Numbers  ICMJE A0081252
Has Data Monitoring Committee No
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 April 2013

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