Long-term OL Study of [S,S]-RBX in Patients With Fibromyalgia

Phase 3TerminatedNCT00607256

Pfizer500 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

500

Conditions

Fibromyalgia

Interventions

[S,S]-reboxetineDRUG

S\_S reboxetine dosed daily.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (79)

Outcomes

Primary Outcomes

12-lead ECG

Time frame: 68 weeks

Hematology/Biochemistry

Time frame: 68 weeks

Adverse events

Time frame: 68 weeks

Physical examination

Time frame: 68 weeks

Vital signs

Time frame: 68 weeks

Secondary Outcomes

Patient Global Impression of Change

Time frame: 68 weeks

Data from ClinicalTrials.gov

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Pfizer Investigational Site

Orangevale, California, United States

Pfizer Investigational Site

Santa Ana, California, United States

Pfizer Investigational Site

Denver, Colorado, 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

West Palm Beach, Florida, United States

Pfizer Investigational Site

Moline, Illinois, United States

Pfizer Investigational Site

Prairie Village, Kansas, United States

Pfizer Investigational Site

Lexington, Kentucky, United States

...and 69 more locations