Duloxetine Versus Placebo for Fibromyalgia - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00489073

Purpose

The primary purpose of this study is to determine if duloxetine reduces pain severity in patients with fibromyalgia.

Condition	Intervention	Phase
Fibromyalgia	Drug: duloxetine Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Duloxetine Versus Placebo in the Treatment of Fibromyalgia Patients With or Without Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression Fibromyalgia

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

To assess efficacy of duloxetine 60 mg twice daily (BID) compared with placebo on reduction of pain severity, measured by average pain item of Brief Pain Inventory (BPI) in patients with ACR-defined primary fibromyalgia, with or without major depression.

Secondary Outcome Measures:

To evaluate the efficacy of duloxetine 60 mg once daily (QD) compared with placebo during a 12-week, double-blind, acute therapy phase on the reduction of pain severity as measured by the average pain item of the Brief Pain Inventory (BPI).
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of the area under the curve of pain relief as derived from BPI average pain score
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Fibromyalgia Impact Questionnaire (FIQ) total score
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on improvement of Brief Pain Inventory (BPI) severity (worst pain, least pain, pain right now) and interference scores
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Tender point pain thresholds: mean thresholds and number of points with a low threshold
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Clinical Global Impression of Severity (CGI)
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Patient Global Impression of Improvement (PGI)
To evaluate efficacy of duloxetine 60 mg QD and 60 mg BID vs. placebo during a 12-week, double-blind, acute therapy phase on the improvement of Hamilton Depression 17- item Rating Scale (HAMD17) total score
To demonstrate that the effect of duloxetine 60 mg QD and duloxetine 60 mg BID on the BPI average pain score is independent of the presence or absence of a major depressive disorder (MDD) as defined by DSM-IV.
To evaluate whether improvement in pain severity (assessed by BPI average pain score) is direct analgesic effect of duloxetine therapy and independent of treatment effect on mood improvement, as measured by total score of HAMD17

Estimated Enrollment:	345
Study Start Date:	November 2002
Study Completion Date:	December 2003

Eligibility

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

Criteria

Inclusion Criteria:

You are male or female outpatient at least 18 years of age with fibromyalgia. Females of child-bearing potential must test negative on a pregnancy test at visit 1.

Exclusion Criteria:

Serious or unstable cardiovascular, hepatic, renal, respiratory, or hematologic illness, symptomatic peripheral vascular disease, or other medical condition (including unstable hypertension and not clinically euthyroid) or psychological conditions that in the opinion of the investigator would compromise participation or be likely to lead to hospitalization during the course of the study.
Abnormal thyroid-stimulating hormone concentrations.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489073

Locations

United States, Indiana
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, United States

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 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:	6158, F1J-MC-HMCA
Study First Received:	June 19, 2007
Last Updated:	June 19, 2007
ClinicalTrials.gov Identifier:	NCT00489073 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Fibromyalgia
Myofascial Pain Syndromes
Psychotropic Drugs
Pain
Depressive Disorder, Major
Rheumatic Diseases
Depressive Disorder

Serotonin Uptake Inhibitors
Serotonin
Duloxetine
Dopamine
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Mental Disorders
Mood Disorders
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Duloxetine
Neuromuscular Diseases
Musculoskeletal Diseases
Mental Disorders
Therapeutic Uses

Antidepressive Agents
Myofascial Pain Syndromes
Fibromyalgia
Nervous System Diseases
Rheumatic Diseases
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscular Diseases
Serotonin Agents
Mood Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 06, 2009