Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
343 participants
INTERVENTIONAL
2012-02-06
2016-10-31
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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Pregabalin
pregabalin
Pregabalin capsule, 300-450mg/day, twice daily
Placebo
Matched placebo
placebo
Placebo, twice daily
Interventions
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pregabalin
Pregabalin capsule, 300-450mg/day, twice daily
placebo
Placebo, twice daily
Eligibility Criteria
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Inclusion Criteria
* Meeting the ACR (America College of Rheumatology) criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
* At screening (V1) and randomization (V2), patients must have a score of no less than 40 mm on the Pain Visual Analog Scale (VAS)
* At randomization (V2), at least 4 pain diaries must be completed satisfactorily within the last 7 days and the average pain score must be no less than 4
Exclusion Criteria
* Patients with other severe pain due to other conditions (eg, DPN or PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia
* Patients with any widespread inflammatory musculoskeletal disorders, widespread rheumatic diseases other than fibromyalgia, active infections, or untreated endocrine disorders
* CLcr less than 60 mL/min (estimated from serum creatinine)
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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Department of Rheumatism And Immunity, The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Anhui Province Hospital
Hefei, Anhui, China
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Southwest Hospital of the Third Military Medical University,PLA
Chongqing, Chongqing Municipality, China
Department of Neurology,General Hospital of Guangzhou Military Command of PLA
Guangzhou, Guangdong, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Department of Neurology,The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong, China
The Third Affiliated Hospital Of Sun Yat-sen University
Guangzhou, Guangdong, China
Rheumatology Department, The first Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Rheumatology Department, The second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Xiangya Hospital of Centre-south University
Changsha, Kaifu District, Hunan, China
The Second Affiliated Hospital to Nanchang University
Nanchang, Jiangxi, China
Zhongshan Hospital Fudan University, Rheumatology Department
Shanghai, Shanghai Municipality, China
Xijing Hospital, The Fourth Military Medical University
Xi’an, Shanxi, China
Si Chuan Huaxi Hospital/Rheumatology Department
Chengdu, Sichuan, China
The First Affiliated Hospital of Kunming Medical University/ Rheumatology and Immunology Department
Kunming, Yunnan, China
The First Affiliated Hospital of Wenzhou Medical University/Neurology Department
Wenzhou, Zhejiang, China
China-Japan Friendship Hospital/Rheumatology Department
Beijing, , China
Peking Union Medical College Hospital/Rheumatology Department
Beijing, , China
PLA. The Military General Hospital of Beijing
Beijing, , China
Rheumatology and Immunology Dept., Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Rheumatology and Immunology Department, Shanghai Changzheng Hospital
Shanghai, , China
Countries
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References
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Zhang X, Xu H, Zhang Z, Li Y, Pauer L, Liao S, Zhang F. Efficacy and Safety of Pregabalin for Fibromyalgia in a Population of Chinese Subjects. J Pain Res. 2021 Feb 25;14:537-548. doi: 10.2147/JPR.S281483. eCollection 2021.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081241
Identifier Type: -
Identifier Source: org_study_id
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