Status:
COMPLETED
A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.
Lead Sponsor:
Pfizer
Conditions:
Fibromyalgia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a study to investigate the effectiveness and safety of \[S,S\]-Reboxetine in relieving the symptoms of Fibromyalgia in patients. A previous study demonstrated clinically meaningful treatment e...
Eligibility Criteria
Inclusion
- Male or female of any race, at least 18 years of age
- Patients must meet the ACR criteria for fibromyalgia (ie, widespread pain present for at least 3 months, and pain in at least 11 of 18 specific tender point sites)
Exclusion
- Patients with other severe pain (eg, Diabetic Peripheral Neuropathy and PostHerpetic Neuralgia) that may confound assessment or self evaluation of the pain associated with fibromyalgia
- Patients with any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), active infection, or untreated endocrine disorder
- A current or recent diagnosis (last 6 months) or episode of major depressive disorder, dysthymia and/or uncontrolled depression
- History of mania, hypomania, other psychotic disorder, or current mood disorder with psychotic features
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
1129 Patients enrolled
Trial Details
Trial ID
NCT00612170
Start Date
December 1 2007
End Date
May 1 2009
Last Update
December 12 2019
Active Locations (145)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35242
2
Pfizer Investigational Site
Huntsville, Alabama, United States, 35802
3
Pfizer Investigational Site
Tallassee, Alabama, United States, 36078
4
Pfizer Investigational Site
Chandler, Arizona, United States, 85225