Pregabalin for Treatment of Patients With Postherpetic Neuralgia (PHN)
NCT ID: NCT01455428
Last Updated: 2021-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
223 participants
INTERVENTIONAL
2011-12-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lyrica (pregabalin)
Lyrica (pregabalin)
Capsule, 300 mg/d, BID, 8 weeks treatment
Placebo
Placebo
Capsule, 300 mg/d, BID, 8 weeks treatment
Interventions
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Lyrica (pregabalin)
Capsule, 300 mg/d, BID, 8 weeks treatment
Placebo
Capsule, 300 mg/d, BID, 8 weeks treatment
Eligibility Criteria
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Inclusion Criteria
* Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia (PHN). Subjects must have pain present for ﹥3 months after healing of the acute herpes zoster skin rash
* At screening (V1), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
* At randomization (V2), subjects must have a score ≥40mm on the 100-mm visual analog scale (VAS) of the Short Form-McGill Pain Questionnaire (SF-MPQ, see Appendix 3)
* At randomization (V2), subjects must have completed at least 5 daily pain diaries (DPRS, see Appendix 2) and have an average daily pain score ≥4 over the past 7 days
Exclusion Criteria
* Subjects who have a high variability in pain scores during the 1 week screening period, with any difference between two scores ﹥3
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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Peking University First Hospital
Beijing, Beijing Municipality, China
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Neurology Department, Jiangsu Province Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University/Neurology Department
Suzhou, Jiangsu, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
The First Affiliated Hospital of College of Medicine, Zhejiang University/Dermatology and STD Dept.
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital Affiliated of College of Medicine, Zhejiang University/Neurology Dept.
Hangzhou, Zhejiang, China
Beijing Friendship Hospital, Capital Medical University/Department of Internal Neurology
Beijing, , China
Peking University Third Hospital, Neurology Department
Beijing, , China
Neurology Department, Beijing Hospital of the Ministry of Health
Beijing, , China
West China Hospital of Sichuan University, Neurology Department
Chengdu/wuhou D, , China
the first affiliated hospital ,chongqing medical university, Department of Neurology
Chongqing, , China
GuangZhou First Municipal People's Hospital
Guangzhou, , China
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, , China
Neurology Department, Shanghai Changzheng Hospital
Shanghai, , China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, , China
Huashan Hospital, Fudan University/Neurology Department
Shanghai, , China
Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department
Shanghai, , China
Tianjin Medical University General Hospital, Dermatological Department
Tianjin, , China
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081276
Identifier Type: -
Identifier Source: org_study_id
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