Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
107 participants
INTERVENTIONAL
2010-05-31
2014-12-31
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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Placebo
placebo
matching placebo capsules twice daily.
drug-pregabalin
pregabalin (Lyrica)
75-450mg/day pregabalin dose optimised at start of study
Interventions
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placebo
matching placebo capsules twice daily.
pregabalin (Lyrica)
75-450mg/day pregabalin dose optimised at start of study
Eligibility Criteria
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Inclusion Criteria
* 12-17 years of age
Exclusion Criteria
* Previous treatment with pregabalin
* Patients taking excluded medication
12 Years
17 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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Childrens Hospital Los Angeles
Los Angeles, California, United States
Apex Research Institute
Santa Ana, California, United States
Eileen Messing, Psy D.
Delray Beach, Florida, United States
Arthritis Associates of South Florida
Delray Beach, Florida, United States
Delray Research Associates
Delray Beach, Florida, United States
Florida Medical Center and Research, Inc.
Miami, Florida, United States
Harmony Clinical Research, Incorporated
North Miami Beach, Florida, United States
Rheumatology Associates of Central Florida, PA
Orlando, Florida, United States
Medical Research & Health Education Foundation, Inc.
Columbus, Georgia, United States
North Georgia Rheumatology, PC
Lawrenceville, Georgia, United States
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
Kosair Children's Hospital
Louisville, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
University Pediatric Rheumatology of Kentucky, LLC
Louisville, Kentucky, United States
University of Massachusetts Memorial Medical Center Department of Pediatrics
Worcester, Massachusetts, United States
A&A Pain Institute of St. Louis
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
Duke Medicine Plaza
Raleigh, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Akron Children's Hospital
Boardman, Ohio, United States
Boardman Medical Pavilion
Boardman, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Research Institute at Nationwide Children's Hospital
Columbus, Ohio, United States
St. Christopher's Hospital for Children / Section of Rheumatology
Philadelphia, Pennsylvania, United States
Medical University of South Carolina, Pediatric Rheumatology
Charleston, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
MUSC University Children's Hospital
Charleston, South Carolina, United States
Carolina Research Center
Myrtle Beach, South Carolina, United States
Fatigue Consultation Clinic
Salt Lake City, Utah, United States
Bioregeneracni a rehabilitacni centrum
Říčany, , Czechia
Krishna Institute of Medical Sciences Ltd
Secunderabad, Andhra Pradesh, India
Mallikatta Neuro Centre
Mangalore, Karnataka, India
Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
Nagpur, Maharashtra, India
Department of Physical Medicine & Rehabilitation
Lucknow, Uttar Pradesh, India
National Taiwan University Hospital
Taipei, , Taiwan
Countries
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References
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Arnold LM, Schikler KN, Bateman L, Khan T, Pauer L, Bhadra-Brown P, Clair A, Chew ML, Scavone J; Pregabalin Adolescent Fibromyalgia Study Group. Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study. Pediatr Rheumatol Online J. 2016 Jul 30;14(1):46. doi: 10.1186/s12969-016-0106-4.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2010-019521-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
A0081180
Identifier Type: -
Identifier Source: org_study_id
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