A Study of Duloxetine in the Treatment of Fibromyalgia

A 1-Year Safety Study of Duloxetine in Patients With Fibromyalgia Syndrome

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00125892

Enrollment

320

Registered

2005-08-02

Start date

2005-07-31

Completion date

2007-03-31

Last updated

2007-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Brief summary

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

Interventions

DRUGduloxetine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Evaluate safety and efficacy of duloxetine in patients diagnosed with fibromyalgia syndrome	—

Secondary

Measure	Time frame
Evaluate persistence of efficacy	—
Evaluate long-term differences in efficacy in different doses	—
Evaluate gains in efficacy in non-responders	—

Countries

Argentina, Australia, Brazil, Canada, Mexico, Poland, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026