A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia
NCT ID: NCT00673452
Last Updated: 2010-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
530 participants
INTERVENTIONAL
2008-06-30
2009-07-31
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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Duloxetine
60-120 mg, oral, every day, 12 weeks
duloxetine hydrochloride
60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase).
Placebo
oral, daily, 12 weeks
placebo
oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)
Interventions
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duloxetine hydrochloride
60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase).
placebo
oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged 18 and older who meet criteria for fibromyalgia as defined by the American College of Rheumatology
* have a score of at least 4 on the average pain item of the Brief Pain Inventory (BPI) (modified short form) at visits 1 and 2
* all females must test negative for pregnancy at the time of enrollment
* have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.
Exclusion Criteria
* have regional pain syndrome, multiple surgeries or failed back syndrome
* have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Eli Lilly
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Los Angeles, California, United States
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Pasadena, California, United States
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Cromwell, Connecticut, United States
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Danbury, Connecticut, United States
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Bradenton, Florida, United States
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DeLand, Florida, United States
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Fort Myers, Florida, United States
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Orlando, Florida, United States
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South Miami, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Oak Brook, Illinois, United States
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Lafayette, Indiana, United States
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Prairie Village, Kansas, United States
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Rockville, Maryland, United States
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Belmont, Massachusetts, United States
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Fall River, Massachusetts, United States
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Newton, Massachusetts, United States
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Springfield, Massachusetts, United States
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Ann Arbor, Michigan, United States
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St Louis, Missouri, United States
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Edison, New Jersey, United States
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Piscataway, New Jersey, United States
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Greensboro, North Carolina, United States
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Cincinnati, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Myrtle Beach, South Carolina, United States
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Dallas, Texas, United States
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Lake Jackson, Texas, United States
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San Antonio, Texas, United States
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Waco, Texas, United States
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Wichita Falls, Texas, United States
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West Jordan, Utah, United States
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Bellevue, Washington, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Middleton, Wisconsin, United States
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Hato Rey, , Puerto Rico
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Ponce, , Puerto Rico
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San Juan, , Puerto Rico
Countries
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References
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Mohs R, Mease P, Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. The effect of duloxetine treatment on cognition in patients with fibromyalgia. Psychosom Med. 2012 Jul-Aug;74(6):628-34. doi: 10.1097/PSY.0b013e31825b9855. Epub 2012 Jun 28.
Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial. Arthritis Res Ther. 2011 Jun 13;13(3):R86. doi: 10.1186/ar3359.
Arnold LM, Clauw D, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Flexible dosed duloxetine in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2010 Dec;37(12):2578-86. doi: 10.3899/jrheum.100365. Epub 2010 Sep 15.
Other Identifiers
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F1J-US-HMGB
Identifier Type: OTHER
Identifier Source: secondary_id
12220
Identifier Type: -
Identifier Source: org_study_id
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