A Study of Duloxetine in the Treatment of Fibromyalgia

This study has been completed.

First Received: July 29, 2005 Last Updated: May 16, 2007 History of Changes

Sponsors and Collaborators:	Eli Lilly and Company Boehringer Ingelheim Pharmaceuticals
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00125892

Purpose

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

Condition	Intervention	Phase
Fibromyalgia	Drug: duloxetine	Phase III

MedlinePlus related topics: Fibromyalgia

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety Study
Official Title:	A 1-Year Safety Study of Duloxetine in Patients With Fibromyalgia Syndrome

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Evaluate persistence of efficacy
Evaluate long-term differences in efficacy in different doses
Evaluate gains in efficacy in non-responders

Estimated Enrollment:	320
Study Start Date:	July 2005
Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125892

Show 27 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	9075, F1J-MC-HMEH
Study First Received:	July 29, 2005
Last Updated:	May 16, 2007
ClinicalTrials.gov Identifier:	NCT00125892 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Fibromyalgia
Myofascial Pain Syndromes
Psychotropic Drugs
Pain
Rheumatic Diseases
Serotonin Uptake Inhibitors

Duloxetine
Serotonin
Dopamine
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Fibromyalgia
Myofascial Pain Syndromes
Physiological Effects of Drugs
Nervous System Diseases
Psychotropic Drugs
Rheumatic Diseases

Serotonin Uptake Inhibitors
Duloxetine
Pharmacologic Actions
Serotonin Agents
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on May 06, 2009