Status:
COMPLETED
A Study for Adult Patients With Fibromyalgia
Lead Sponsor:
Eli Lilly and Company
Conditions:
Fibromyalgia, Primary
Fibromyalgia, Secondary
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is effective in the treatment of fibromyalgia compared to placebo.
Eligibility Criteria
Inclusion
- Meet study criteria for fibromyalgia diagnosis.
Exclusion
- Have previously or are currently taking duloxetine.
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
308 Patients enrolled
Trial Details
Trial ID
NCT00965081
Start Date
September 1 2009
End Date
November 1 2010
Last Update
November 3 2011
Active Locations (4)
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1
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, 45040
2
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, 97000
3
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, 64040
4
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, 58000