Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1025 participants
INTERVENTIONAL
2006-04-30
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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Placebo
Placebo, oral administration, twice daily for 12 weeks
Placebo
Placebo, oral administration, twice daily for 12 weeks
Milnacipran
Milnacipran 100mg/day (50mg BID \[twice a day\])
Milnacipran 100mg
Milnacipran 100mg per day (50mg BID \[twice a day\])
Interventions
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Placebo
Placebo, oral administration, twice daily for 12 weeks
Milnacipran 100mg
Milnacipran 100mg per day (50mg BID \[twice a day\])
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* depression,
* suicidal risk,
* substance abuse,
* pulmonary dysfunction,
* renal impairment,
* active cardiac disease,
* liver disease,
* autoimmune disease,
* cancer,
* inflammatory bowel disease
18 Years
70 Years
ALL
No
Sponsors
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Cypress Bioscience, Inc.
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Forest Research Institute, a subsidiary of Forest Laboratories, Inc.
Locations
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Forest Investigative Site
Tuscaloosa, Alabama, United States
Forest Investigative Site
Fresno, California, United States
Forest Investigative Site
Pismo Beach, California, United States
Forest Investigative Site
Vista, California, United States
Forest Investigative Site
St. Petersburg, Florida, United States
Forest Investigative Site
St. Petersburg, Florida, United States
Forest Investigative Site
Stuart, Florida, United States
Forest Investigative Site
Atlanta, Georgia, United States
Forest Investigative Site
Springfield, Massachusetts, United States
Forest Investigative Site
Worcester, Massachusetts, United States
Forest Investigative Site
Omaha, Nebraska, United States
Forest Investigative Site
Haddon Heights, New Jersey, United States
Forest Investigative Site
Johnson City, New York, United States
Forest Investigative Site
Syracuse, New York, United States
Forest Investigative Site
Greensboro, North Carolina, United States
Forest Investigative Site
Cleveland, Ohio, United States
Forest Investigative Site
Columbus, Ohio, United States
Forest Investigative Site
Toledo, Ohio, United States
Forest Investigative Site
Eugene, Oregon, United States
Forest Investigative Site
Mechanicsburg, Pennsylvania, United States
Forest Investigative Site
Anderson, South Carolina, United States
Forest Investigative Site
Greer, South Carolina, United States
Forest Investigative Site
Richardson, Texas, United States
Forest Investigative Site
Virginia Beach, Virginia, United States
Countries
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References
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Saxe PA, Arnold LM, Palmer RH, Gendreau RM, Chen W. Short-term (2-week) effects of discontinuing milnacipran in patients with fibromyalgia. Curr Med Res Opin. 2012 May;28(5):815-21. doi: 10.1185/03007995.2012.677418. Epub 2012 Apr 10.
Arnold LM, Gendreau RM, Palmer RH, Gendreau JF, Wang Y. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Sep;62(9):2745-56. doi: 10.1002/art.27559.
Other Identifiers
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MLN-MD-03
Identifier Type: -
Identifier Source: org_study_id
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