An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
NCT ID: NCT01202227
Last Updated: 2021-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
104 participants
INTERVENTIONAL
2010-09-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pregabalin
Flexible dosing in 4 weeks followed by 48 weeks maintenance and one week taper period
pregabalin
Pregabalin capsules taken twice a daily (150-600mg/day)
Interventions
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pregabalin
Pregabalin capsules taken twice a daily (150-600mg/day)
Eligibility Criteria
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Inclusion Criteria
* Subjects who completed assessments of all efficacy endpoints until the end of the treatment phase of the preceding Study A0081107 (V7);
* 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
* 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;
18 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Chubu Rosai Hospital
Nagoya, Aichi-ken, Japan
Kimura Clinic
Nagoya, Aichi-ken, Japan
Nagoya Kyoritsu Clinic
Nagoya, Aichi-ken, Japan
Senboku Kumiai General Hospital
Daisen, Akita, Japan
Go neurosurgical clinic
Chikushi-gun, Fukuoka, Japan
Spinal Injuries Center
Iizuka, Fukuoka, Japan
Brain Attack Center Ota Memorial Hospital
Fukuyama, Hiroshima, Japan
Hokkaido Chuo Rosai Hospital Sekison Center
Bibai, Hokkaido, Japan
Hakodate Central General Hospital
Hakodate, Hokkaido, Japan
Kobe Tokushukai Hospital
Kobe, Hyōgo, Japan
Aida Kinen Rehabilitation Hospital
Moriya, Ibaraki, Japan
General Hanamaki Hospital
Hanamaki, Iwate, Japan
Uchida Rehabilitation Orthopedic Clinic
Kawasaki, Kanagawa, Japan
Kumamoto Rehabilitation Hospital
Kikuchi-gun, Kumamoto, Japan
Kohnan Hospital
Sendai, Miyagi, Japan
Sendai Pain Clinic
Sendai, Miyagi, Japan
National Hospital Organization Niigata National Hospital
Kashiwazaki, Niigata, Japan
Nakamura Hospital
Beppu, Oita Prefecture, Japan
Kitasato University Kitasato Institute Medical Center Hospital
Kitamoto, Saitama, Japan
Kamitsuga General Hospital
Kanuma, Tochigi, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
Jukoukai hospital
Koto-ku, Tokyo, Japan
National Hospital Organization, Murayama Medical Center
Musashimurayama-shi, Tokyo, Japan
Okitama Public General Hospital
Higashiokitama-gun, Yamagata, Japan
Tokushima University Hospital
Tokushima, , Japan
National Hospital Organization Yamagata Hospital
Yamagata, , Japan
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081252
Identifier Type: -
Identifier Source: org_study_id
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