Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
308 participants
INTERVENTIONAL
2009-09-30
2010-11-30
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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Duloxetine
Duloxetine
30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Placebo
Placebo
QD po at the same time each day for 12 weeks
Interventions
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Duloxetine
30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks
Placebo
QD po at the same time each day for 12 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Have been diagnosed with certain psychoses, bipolar or schizoaffective disorder
* Have pain symptoms that are difficult to differentiate from fibromyalgia.
* Have seizure disorder, uncontrolled narrow angle glaucoma, or acute liver injury (such as hepatitis) or severe cirrhosis.
* Have had any primary Axis 1 diagnosis other than major depressive disorder or generalized anxiety disorder within the past year.
* Are pregnant or breast-feeding
* Have a current or previous diagnosis of rheumatoid, infectious or inflammatory arthritis or an autoimmune disease
* Have a regional pain syndrome, failed back syndrome or chronic localized pan related to any past surgery
* Have a serious unstable medical illness
* Have a history of substance abuse or dependence within the past year
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guadalajara, , Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mérida, , Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Monterrey, , Mexico
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Morelia, , Mexico
Countries
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Other Identifiers
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F1J-MC-HMGG
Identifier Type: OTHER
Identifier Source: secondary_id
12873
Identifier Type: -
Identifier Source: org_study_id