Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome
NCT ID: NCT00190866
Last Updated: 2007-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
210 participants
INTERVENTIONAL
2005-06-30
2007-06-30
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
Interventions
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Duloxetine
placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Have any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
* Have any primary diagnosis of anxiety disorder within the past year (including panic disorder, agoraphobia, OCD, PTSD, GAD and social phobia)
* Have regional pain syndrome, multiple surgeries or failed back syndrome
* Have a confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infective arthritis, or an autoimmune disease (e.g. lupus)
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Eli Lilly and Company
INDUSTRY
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 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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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Burbank, California, United States
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Sherman Oaks, California, United States
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Walnut Creek, California, United States
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Danbury, Connecticut, United States
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DeLand, Florida, United States
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Fort Myers, Florida, United States
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Miami, Florida, United States
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Lafayette, Indiana, United States
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Prairie Village, Kansas, United States
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Fall River, Massachusetts, United States
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Springfield, Massachusetts, United States
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St Louis, Missouri, United States
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Albany, New York, United States
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Greensboro, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Toledo, Ohio, 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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Wyomissing, Pennsylvania, United States
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Cranston, Rhode Island, United States
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Mt. Pleasant, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Austin, 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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Woodstock, Vermont, United States
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Kirkland, Washington, United States
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Seattle, Washington, United States
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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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Mease PJ, Spaeth M, Clauw DJ, Arnold LM, Bradley LA, Russell IJ, Kajdasz DK, Walker DJ, Chappell AS. Estimation of minimum clinically important difference for pain in fibromyalgia. Arthritis Care Res (Hoboken). 2011 Jun;63(6):821-6. doi: 10.1002/acr.20449.
Russell JI, Mease PJ, Smith TR, Kajdasz DK, Wohlreich MM, Detke MJ, Walker DJ, Chappell AS, Arnold LM. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain. 2008 Jun;136(3):432-444. doi: 10.1016/j.pain.2008.02.024. Epub 2008 Apr 18.
Other Identifiers
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F1J-MC-HMCJ
Identifier Type: -
Identifier Source: secondary_id
6222
Identifier Type: -
Identifier Source: org_study_id