Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
NCT ID: NCT01271933
Last Updated: 2021-01-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
441 participants
INTERVENTIONAL
2011-03-31
2012-07-31
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
QUADRUPLE
Study Groups
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Pregabalin
pregabalin
controlled release tablet; 165-495 mg/day; given once daily
Placebo
placebo
matching placebo tablet; given once daily
Interventions
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pregabalin
controlled release tablet; 165-495 mg/day; given once daily
placebo
matching placebo tablet; given once daily
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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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Andrew O. Schreiber, MD
Orange, California, United States
Apex Research Institute
Santa Ana, California, United States
Paddock Park Clinical Research
Ocala, Florida, United States
Broward Research Group
Pembroke Pines, Florida, United States
Meridien Research
Tampa, Florida, United States
Arthritis Care Center
Moline, Illinois, United States
Davis Clinic, Inc
Indianapolis, Indiana, United States
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States
Boston Clinical Trials
Boston, Massachusetts, United States
Beacon Clinical Research, LLC
Brockton, Massachusetts, United States
The Center for Pharmaceutical Research, PC
Kansas City, Missouri, United States
Mercy Health Research
St Louis, Missouri, United States
Quality Clinical Research, Inc.
Omaha, Nebraska, United States
AB Clinical Trials
Las Vegas, Nevada, United States
Albuquerque Neuroscience, Incorporated
Albuquerque, New Mexico, United States
Social Psychiatry Research Institute
Brooklyn, New York, United States
Trinity Health Organization
Minot, North Dakota, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Radiant Research,
Columbus, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Sunstone Medical Research, LLC
Medford, Oregon, United States
Allegheny Pain Management
Altoona, Pennsylvania, United States
East Penn RheumatologyAssociates, P.C.
Bethlehem, Pennsylvania, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
Fatigue Consultation Clinic
Salt Lake City, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Tacoma Center for Arthritis Research, PS
Tacoma, Washington, United States
Dr. Alexander McIntyre Inc.
Penticton, British Columbia, Canada
Rivergrove Medical Clinic
Winnipeg, Manitoba, Canada
Maritime Research Center
Bathurst, New Brunswick, Canada
Clinique Medicale Nepisiguit
Bathurst, New Brunswick, Canada
Tri-Hospital Sleep Laboratory West
Mississauga, Ontario, Canada
Canadian Phase Onward Inc.
Toronto, Ontario, Canada
Sleep & Alertness Research Inc.
Toronto, Ontario, Canada
West Island Rheumatology Research Associates
Pointe-Claire, Quebec, Canada
Groupe de Recherche en Rhumatologie et Maladie Osseuses (GRMO Inc.)
Québec, Quebec, Canada
Diex Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Mahavir Hospital & Research Centre
Hyderabad, Andhra Pradesh, India
Chanre Rheumatology & Immunology Center & Research
Bangalore, Karnataka, India
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, India
Sahyadri Clinical Research & Development Center,
Pune, Maharashtra, India
Sahyadri Speciality Hospital
Pune, Maharashtra, India
Punjab Rheumatology Centre
Ludhiana, Punjab, India
Department of Rheumatology
Lucknow, Uttar Pradesh, India
Indian Spinal Injuries Centre
New Delhi, , India
Chang Gung Medical Foundation-Linkou Branch
Kwei Shan Town, Taoyuan County, Taiwan
Chang-Hua Christian Hospital
Changhua, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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References
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Arnold LM, Arsenault P, Huffman C, Patrick JL, Messig M, Chew ML, Sanin L, Scavone JM, Pauer L, Clair AG. Once daily controlled-release pregabalin in the treatment of patients with fibromyalgia: a phase III, double-blind, randomized withdrawal, placebo-controlled study. Curr Med Res Opin. 2014 Oct;30(10):2069-83. doi: 10.1185/03007995.2014.928275. Epub 2014 Jun 27.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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FIBROMYALGIA
Identifier Type: OTHER
Identifier Source: secondary_id
A0081245
Identifier Type: -
Identifier Source: org_study_id
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