Randomized, Double-Blind, Placebo-Controlled Trial Of Pregabalin In Patients With Fibromyalgia.
NCT ID: NCT00333866
Last Updated: 2021-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
747 participants
INTERVENTIONAL
2006-07-31
2007-11-30
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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1
pregabalin
600mg/day
2
pregabalin
450mg/day
3
pregabalin
300mg/day
4
placebo
placebo
Interventions
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pregabalin
600mg/day
pregabalin
450mg/day
pregabalin
300mg/day
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* A score of more or equal to 40 mm on the Pain Visual Analog Scale (VAS) and a an average score more or equal to 4 on 4 daily pain diaries
Exclusion Criteria
* Patients with severe depression
* Patients taking excluded medications
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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Pfizer Investigational Site
Warrawong, New South Wales, Australia
Pfizer Investigational Site
Maroochydore, Queensland, Australia
Pfizer Investigational Site
Clayton, Victoria, Australia
Pfizer Investigational Site
Fitzroy, Victoria, Australia
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Kelowna, British Columbia, Canada
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Pfizer Investigational Site
Bathurst, New Brunswick, Canada
Pfizer Investigational Site
St. John's, Newfoundland and Labrador, Canada
Pfizer Investigational Site
Hawkesbury, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
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Drummondville, Quebec, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Pointe-Claire, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Frederiksberg, , Denmark
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Svendborg, , Denmark
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Montpellier, Cedex 5, France
Pfizer Investigational Site
Lille, Cedex, France
Pfizer Investigational Site
Clermont-Ferrand, , France
Pfizer Investigational Site
Paris, , France
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Saint-Etienne, , France
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Bad Säckingen, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bonn, , Germany
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Mannheim, , Germany
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München, , Germany
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Indore, Madhya Pradesh, India
Pfizer Investigational Site
Ludhiana, Punjab, India
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Ludhiana, Punjab, India
Pfizer Investigational Site
Lucknow, Uttar Pradesh, India
Pfizer Investigational Site
Bari, , Italy
Pfizer Investigational Site
Benevento, , Italy
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Bologna, , Italy
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Chieti Scalo, , Italy
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Perugia, , Italy
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Pisa, , Italy
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México, D. F., Mexico
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León, Guanajuato, Mexico
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Monterrey, Nuevo León, Mexico
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San Luis Potosí City, , Mexico
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Alkmaar, , Netherlands
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Den Helder, , Netherlands
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Leeuwarden, , Netherlands
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Rotterdam, , Netherlands
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Zwolle, , Netherlands
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Suwon, Kyeongki-do, South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Guadalajara, , Spain
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Linköping, , Sweden
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Mölndal, , Sweden
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Örebro, , Sweden
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Stockholm, , Sweden
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Lausanne, , Switzerland
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Zurich, , Switzerland
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Zurich, , Switzerland
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Manchester, Greater Manchester, United Kingdom
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Greenock, Renfrewshire, United Kingdom
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North Shields, Tyne and Wear, United Kingdom
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London, , United Kingdom
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Poole, , United Kingdom
Pfizer Investigational Site
Caracas, Distrito Federal, Venezuela
Pfizer Investigational Site
Caracas, Distrito Federal, Venezuela
Pfizer Investigational Site
Caracas, Miranda, Venezuela
Countries
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References
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Clair A, Emir B. The safety and efficacy of pregabalin for treating subjects with fibromyalgia and moderate or severe baseline widespread pain. Curr Med Res Opin. 2016;32(3):601-9. doi: 10.1185/03007995.2015.1134463. Epub 2016 Jan 27.
Pauer L, Winkelmann A, Arsenault P, Jespersen A, Whelan L, Atkinson G, Leon T, Zeiher B; A0081100 Investigators. An international, randomized, double-blind, placebo-controlled, phase III trial of pregabalin monotherapy in treatment of patients with fibromyalgia. J Rheumatol. 2011 Dec;38(12):2643-52. doi: 10.3899/jrheum.110569. Epub 2011 Oct 1.
Straube S, Moore RA, Paine J, Derry S, Phillips CJ, Hallier E, McQuay HJ. Interference with work in fibromyalgia: effect of treatment with pregabalin and relation to pain response. BMC Musculoskelet Disord. 2011 Jun 3;12:125. doi: 10.1186/1471-2474-12-125.
Bhadra P, Petersel D. Medical conditions in fibromyalgia patients and their relationship to pregabalin efficacy: pooled analysis of Phase III clinical trials. Expert Opin Pharmacother. 2010 Dec;11(17):2805-12. doi: 10.1517/14656566.2010.525217. Epub 2010 Nov 2.
Bennett RM, Russell J, Cappelleri JC, Bushmakin AG, Zlateva G, Sadosky A. Identification of symptom and functional domains that fibromyalgia patients would like to see improved: a cluster analysis. BMC Musculoskelet Disord. 2010 Jun 28;11:134. doi: 10.1186/1471-2474-11-134.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081100
Identifier Type: -
Identifier Source: org_study_id
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