A 14-week, Multi-center Study of [S,S]-Reboxetine in Patients With Fibromyalgia.

Completed · Phase 3 · Has a placebo group

Conditions studied: Fibromyalgia

In brief

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 effects in fibromyalgia, based on pain and functional endpoints.

Key facts

Study ID

NCT00612170

Run by

Pfizer

People needed

1129

Starts

2007-12-01

Expected to finish

2009-05-01

Last updated by the study team

2019-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Huntsville, Alabama, United States
• Pfizer Investigational Site — Tallassee, Alabama, United States
• Pfizer Investigational Site — Chandler, Arizona, United States
• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Carmichael, California, United States
• Pfizer Investigational Site — Elk Grove, California, United States
• Pfizer Investigational Site — Fullerton, California, United States
• Pfizer Investigational Site — Lafayette, California, United States
• Pfizer Investigational Site — Northridge, California, United States
• Pfizer Investigational Site — Oceanside, California, United States
• Pfizer Investigational Site — Roseville, California, United States
• Pfizer Investigational Site — Sacramento, California, United States
• Pfizer Investigational Site — Sacramento, California, United States
• Pfizer Investigational Site — San Jose, California, United States
• Pfizer Investigational Site — Santa Ana, California, United States
• Pfizer Investigational Site — New London, Connecticut, United States
• Pfizer Investigational Site — Brooksville, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Ocala, Florida, United States
• Pfizer Investigational Site — Ocala, Florida, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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