Open Label Extension Study of [S,S]-Reboxetine in Patients With Fibromyalgia

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: [S,S]-Reboxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00754221

A6061053

Details and patient eligibility

About

This is a study to investigate the long-term safety and effectiveness [S,S]-Reboxetine in relieving the symptoms of Fibromyalgia in patients.

Enrollment: 390 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)
• Completed preceding double-blind randomized, controlled trial

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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390 participants in 1 patient group

1

Experimental group

Treatment:

Drug: [S,S]-Reboxetine