Discontinuation Study of the Durability of Effect of Milnacipran for the Treatment of Fibromyalgia
NCT ID: NCT01014585
Last Updated: 2011-09-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
340 participants
INTERVENTIONAL
2009-11-30
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
QUADRUPLE
Study Groups
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1
Placebo tablets administered orally twice daily
Placebo
Placebo tablets administered orally twice daily
2
Milnacipran tablets administered orally twice daily
Milnacipran
Milnacipran tablets administered orally twice daily
Interventions
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Placebo
Placebo tablets administered orally twice daily
Milnacipran
Milnacipran tablets administered orally twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receiving a stable dosage of milnacipran (50-200 mg/d) at Screening/Enrollment (Visit 1)
Exclusion Criteria
* History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
* Myocardial infarction and/or stroke within the prior 12 months
* Mean systolic blood pressure \> 180 mm Hg or mean diastolic blood pressure \> 110 mm Hg at Screening (Visit 1)
* Active liver disease
* Severe renal impairment
* Platelet and bleeding disorders
* Female patients who are pregnant or breastfeeding
ALL
No
Sponsors
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Cypress Bioscience, Inc.
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Joel Trugman, MD
Role: STUDY_DIRECTOR
Forest Research Institute Inc., A Subsidiary of Forest Laboratories Inc
Locations
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Forest Investigative Site 062
Birmingham, Alabama, United States
Forest Investigative Site 065
Birmingham, Alabama, United States
Forest Investigative Site 012
Tucson, Arizona, United States
Forest Investigative Site 007
Fresno, California, United States
Forest Investigative Site 032
Pismo Beach, California, United States
Forest Investigative Site 025
Sacramento, California, United States
Forest Investigative Site 019
San Diego, California, United States
Forest Investigative Site 057
Santa Ana, California, United States
Forest Investigative Site 039
Vista, California, United States
Forest Investigative Site 050
Cromwell, Connecticut, United States
Forest Investigative Site 049
Danbury, Connecticut, United States
Forest Investigative Site 055
Stamford, Connecticut, United States
Forest Investigative Site 011
Delray Beach, Florida, United States
Forest Investigative Site 013
Ocala, Florida, United States
Forest Investigative Site 016
Orlando, Florida, United States
Forest Investigative Site 043
Palm Harbor, Florida, United States
Forest Investigative Site 060
Pembroke Pines, Florida, United States
Forest Investigative Site 066
Atlanta, Georgia, United States
Forest Investigative Site 009
Atlanta, Georgia, United States
Forest Investigative Site 026
Honolulu, Hawaii, United States
Forest Investigative Site 056
Libertyville, Illinois, United States
Forest Investigative Site 038
Peoria, Illinois, United States
Forest Investigative Site 031
Evansville, Indiana, United States
Forest Investigative Site 064
Frederick, Maryland, United States
Forest Investigative Site 030
Newton, Massachusetts, United States
Forest Investigative Site 048
North Dartmouth, Massachusetts, United States
Forest Investigative Site 017
Springfield, Massachusetts, United States
Forest Investigative Site 008
Worcester, Massachusetts, United States
Forest Investigative Site 061
Kalamazoo, Michigan, United States
Forest Investigative Site 020
Jackson, Mississippi, United States
Forest Investigative Site 004
St Louis, Missouri, United States
Forest Investigative Site 033
Cherry Hill, New Jersey, United States
Forest Investigative Site 040
Albuquerque, New Mexico, United States
Forest Investigative Site 035
Great Neck, New York, United States
Forest Investigative Site 014
Rochester, New York, United States
Forest Investigative Site 027
Syracuse, New York, United States
Forest Investigative Site 054
Charlotte, North Carolina, United States
Forest Investigative Site 018
Greensboro, North Carolina, United States
Forest Investigative Site 002
Greenville, North Carolina, United States
Forest Investigative Site 024
Salisbury, North Carolina, United States
Forest Investigative Site 042
Winston-Salem, North Carolina, United States
Forest Investigative Site 003
Cincinnati, Ohio, United States
Forest Investigative Site 005
Cleveland, Ohio, United States
Forest Investigative Site 059
Columbus, Ohio, United States
Forest Investigative Site 044
Eugene, Oregon, United States
Forest Investigative Site 010
Eugene, Oregon, United States
Forest Investigative Site 001
Medford, Oregon, United States
Forest Investigative Site 052
Medford, Oregon, United States
Forest Investigative Site 041
Portland, Oregon, United States
Forest Investigative Site 051
Duncansville, Pennsylvania, United States
Forest Investigative Site 046
Mechanicsburg, Pennsylvania, United States
Forest Investigative Site 028
Anderson, South Carolina, United States
Forest Investigative Site 021
Greer, South Carolina, United States
Forest Investigative Site 006
Salt Lake City, Utah, United States
Forest Investigative Site 015
Chesapeake, Virginia, United States
Forest Investigative Site 047
Seattle, Washington, United States
Forest Investigative Site 036
Wenatchee, Washington, United States
Forest Investigative Site 063
Racine, Wisconsin, United States
Countries
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References
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Clauw DJ, Mease PJ, Palmer RH, Trugman JM, Wang Y. Continuing efficacy of milnacipran following long-term treatment in fibromyalgia: a randomized trial. Arthritis Res Ther. 2013 Aug 16;15(4):R88. doi: 10.1186/ar4268.
Other Identifiers
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MLN-MD-27
Identifier Type: -
Identifier Source: org_study_id
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