An fMRI Study Of Brain Response In Patients With Fibromyalgia
NCT ID: NCT00760474
Last Updated: 2021-01-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
27 participants
INTERVENTIONAL
2009-01-31
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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Pregabalin, then placebo
Pregabalin, then placebo
Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.
Placebo, then pregabalin
Placebo, then pregabalin
Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.
Interventions
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Pregabalin, then placebo
Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.
Placebo, then pregabalin
Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day.
Eligibility Criteria
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Inclusion Criteria
* Fibromyalgia must have been diagnosed at least 6 months prior to be eligible for this study
Exclusion Criteria
18 Years
70 Years
FEMALE
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
Ann Arbor, Michigan, United States
Pfizer Investigational Site
Ann Arbor, Michigan, United States
Countries
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References
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Ichesco E, Peltier SJ, Mawla I, Harper DE, Pauer L, Harte SE, Clauw DJ, Harris RE. Prediction of Differential Pharmacologic Response in Chronic Pain Using Functional Neuroimaging Biomarkers and a Support Vector Machine Algorithm: An Exploratory Study. Arthritis Rheumatol. 2021 Nov;73(11):2127-2137. doi: 10.1002/art.41781. Epub 2021 Sep 22.
Puiu T, Kairys AE, Pauer L, Schmidt-Wilcke T, Ichesco E, Hampson JP, Napadow V, Clauw DJ, Harris RE. Association of Alterations in Gray Matter Volume With Reduced Evoked-Pain Connectivity Following Short-Term Administration of Pregabalin in Patients With Fibromyalgia. Arthritis Rheumatol. 2016 Jun;68(6):1511-21. doi: 10.1002/art.39600.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A0081211
Identifier Type: -
Identifier Source: org_study_id
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