Long-term OL Study of [S,S]-RBX 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

NCT00607256

A6061046

Details and patient eligibility

About

To evaluate the lon-term safety and tolerability of [S,S]-reboxetine in patients with fibromyalgia

Enrollment: 500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of patients meeting the ACR criteria for fibromyalgia (i.e. 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 (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Open Label

Experimental group

Treatment:

Drug: [S,S]-reboxetine