Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy
NCT ID: NCT01332149
Last Updated: 2021-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
626 participants
INTERVENTIONAL
2011-07-31
2014-06-30
Brief Summary
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This study is being conducted according to China registration requirement to submit a reapplication with new local diabetic peripheral neuropathy study as a commitment plus the existing data to apply for Lyrica "pain associated with postherpetic neuralgia" indication after Lyrica "pain associated with postherpetic neuralgia" is approved.
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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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300 mg/day pregabalin (Lyrica)
Patient take pregabalin capsule twice a day
Pregabalin
Subjects in the pregabalin group will start treatment with pregabalin capsule 150 mg/day for 1 week, then their dose will be increased to 300mg/day. After 1-week titration period, dose must be stable during study, no dose adjustment is permitted, and subject who cannot tolerate 300 mg/day pregabalin will be withdrawn.
At the completion of the dose maintenance phase subjects will taper off study medication over a 1-week period. 300 mg/ day subjects will taper to 150 mg/ day.
Placebo
Placebo matched with pregabalin
Subject will take placebo matched with pregabalin twice a day.
Interventions
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Pregabalin
Subjects in the pregabalin group will start treatment with pregabalin capsule 150 mg/day for 1 week, then their dose will be increased to 300mg/day. After 1-week titration period, dose must be stable during study, no dose adjustment is permitted, and subject who cannot tolerate 300 mg/day pregabalin will be withdrawn.
At the completion of the dose maintenance phase subjects will taper off study medication over a 1-week period. 300 mg/ day subjects will taper to 150 mg/ day.
Placebo matched with pregabalin
Subject will take placebo matched with pregabalin twice a day.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of painful, distal, symmetrical, sensorimotor polyneuropathy which is due to diabetes mellitus (Type 1 or 2), and symptoms of painful diabetic neuropathy for 6 months to 5 years (inclusive).
* At the baseline and randomization visits, a score of ≥50 mm on the Visual Analogue Scale, at randomization, subjects must have completed at least 5 daily pain interference diaries, and have an average daily pain score of ≥5 over the past 7 days.
* Patient who are willing and capable to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Women of childbearing potential are willing to use contraception during study.
Exclusion Criteria
* Subject has other kinds of neurological disorder, pain of other reason, or skin condition that could confuse the assessment.
* Subject with any other serious or unstable condition which in the opinion of the investigator might compromise participation in the study.
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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Southwest hospital of the third military medical university/Department of Neurology
Chongqing, Chongqing Municipality, China
Fuzhou General Hospital of Nanjing Military Command
Fuzhou, Fujian, China
Department of Endocrinology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Dept. of Endocrinology, The first Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Dept. of Endocrinology, The second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Tongji Hospital,Tongji Medical College Huazhong University of Science & Technology
Wuhan, Hubei, China
Xiangya Hospital of Centre-south University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Dept. of Endocrinology, The second hospital of Jilin University
Changchun, Jilin, China
Shengjing hospital of china medical university
Shenyang, Liaoning, China
Qilu Hospital of Shandong University/department of internal neurology
Jinan, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital Zhejiang University College of Medicine
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital, School of medicine, Zhejiang University
Hangzhou, Zhejiang, China
Beijing Tiantan Hospital affiliated to Capital Medical University, Neurology Department
Beijing, , China
Peking University Third Hospital
Beijing, , China
Endocrinology Department
Beijing, , China
Beijing Hospital of the Ministry of Health
Beijing, , China
Tongren Hospital Affiliated to Capital Medical University
Beijing, , China
Chinese PLA General Hospital
Beijing, , China
GuangZhou First Municipal People's Hospital
Guangzhou, , China
Shanghai Changzheng Hospital
Shanghai, , China
Huashan Hospital Affiliated Fudan University, Neurology Department
Shanghai, , China
Shanghai Tenth People's Hospital/The Endocrinology Department
Shanghai, , China
Shanghai First People's Hospital
Shanghai, , China
Renji Hospital Shanghai Jiao Tong University School of Medicine/Neurology Department
Shanghai, , 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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A0081265
Identifier Type: -
Identifier Source: org_study_id
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