An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
NCT01202227
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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;
- 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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Descriptive Information | ||||
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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 |
| |||
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 | 104 | |||
Original Estimated Enrollment ICMJE | 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
Inclusion criteria for subjects to be new participants in this study
Exclusion Criteria:
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Sex/Gender ICMJE |
| |||
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 |
| |||
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 |