A Study of Duloxetine in the Treatment of Fibromyalgia

Phase 3CompletedNCT00125892

Eli Lilly and Company320 enrolled

Overview

This study is designed to evaluate duloxetine for the treatment of fibromyalgia syndrome patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

320

Conditions

Fibromyalgia

Interventions

duloxetineDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Meet criteria for primary fibromyalgia syndrome as defined by the American College of Rheumatologists Exclusion Criteria: * Treatment with a monoamine oxidase inhibitor within 14 days prior to Visit 2 or the potential need to take within 5 days after discontinuation from the study. * Any patients judged by their physicians to be at serious suicidal risk. * Have uncontrolled narrow-angle glaucoma

Locations (27)

Outcomes

Primary Outcomes

Evaluate safety and efficacy of duloxetine in patients diagnosed with fibromyalgia syndrome

Secondary Outcomes

Evaluate persistence of efficacy

Evaluate long-term differences in efficacy in different doses

Evaluate gains in efficacy in non-responders

Data from ClinicalTrials.gov

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Buenos Aires, Argentina

Capital Federal, Argentina