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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Fibromyalgia

Treatments: Drug: Placebo; Drug: [S,S]-Reboxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00612170

A6061043

Details and patient eligibility

About

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.

Enrollment: 1,129 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)

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: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,129 participants in 4 patient groups

3

Experimental group

Treatment:

Drug: [S,S]-Reboxetine

Drug: [S,S]-Reboxetine

Drug: [S,S]-Reboxetine

4

Sham Comparator group

Treatment:

Drug: Placebo

1

Experimental group

Treatment:

Drug: [S,S]-Reboxetine

Drug: [S,S]-Reboxetine

Drug: [S,S]-Reboxetine

2

Experimental group

Treatment:

Drug: [S,S]-Reboxetine

Drug: [S,S]-Reboxetine

Drug: [S,S]-Reboxetine