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

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NCT01202227

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Chubu Rosai Hospital
Nagoya, Aichi, Japan
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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

- Platelet count count

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

NCT01202227
Pfizer
Completed
An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain

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An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
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)
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).
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Spinal Cord Diseases
  • Spinal Cord Injuries
  • Neuralgia
  • Pain
Drug: pregabalin
Pregabalin capsules taken twice a daily (150-600mg/day)
Experimental: Pregabalin
Flexible dosing in 4 weeks followed by 48 weeks maintenance and one week taper period
Intervention: Drug: pregabalin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
March 2012
March 2012   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01202227
A0081252
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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