Duloxetine Versus Placebo in the Treatment of FMS - Full Text View

Sponsors and Collaborators:	Eli Lilly and Company Boehringer Ingelheim Pharmaceuticals
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00233025

Purpose

To test the hypothesis that the efficacy and safety of duloxetine has beneficial effects of the reduction of pain severity as measured by the average pain item of the BPI and the PGI-I in patients with fibromyalgia syndrome.

Condition	Intervention	Phase
Fibromyalgia	Drug: Duloxetine Drug: Placebo	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, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Duloxetine 60/120mg Versus Placebo in the Treatment of Fibromyalgia Syndrome

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase
evaluate change in pain measured by Brief Pain Inventory score
evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale

Secondary Outcome Measures:

change from baseline to endpoint on Sheehan Disability Scale total score
assess efficacy of duloxetine vs placebo in first 3-months of therapy measured by change in BPI average score and PGI-I endpoint
evaluate between group differences (duloxetine and placebo) in the first 3-months measured by change in baseline to endpoint in SDS total score
evaluate efficacy of duloxetine versus placebo during 6-month therapy as measured by:
FIQ
CGI-Severity
Tender-point pain thresholds
MFI
Percent of patients with 50% improvement in BPI avg. pain score
BPI Severity
evaluate duloxetine 60/120mg (QD) versus placebo during 6-month therapy as measured by the following health outcome measures:
SF-36
EQ-5D

Estimated Enrollment:	320
Study Start Date:	September 2005
Study Completion Date:	June 2007

Eligibility

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

Criteria

Inclusion Criteria:

meet criteria from primary FMS as defined by the ACR: widespread aching pain in all four quadrants of the body and axial skeleton and greater than or equal to 11 of 18 tender points under digital palpation examination
measure average pain item of the BPI at Visits 1 and 2

Exclusion Criteria:

have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
have regional pain syndrome, multiple surgeries or failed back syndrome
have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)
have current primary Axis I diagnosis other than major depressive disorder (MDD), including a current diagnosis of dysthymia

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233025

Show 34 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 - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

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

Study ID Numbers:	9072, F1J-MC-HMEF
Study First Received:	October 3, 2005
Last Updated:	August 22, 2007
ClinicalTrials.gov Identifier:	NCT00233025
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine
Muscular Diseases
Neuromuscular Diseases
Musculoskeletal Diseases
Myofascial Pain Syndromes

Fibromyalgia
Pain
Rheumatic Diseases
Serotonin
Duloxetine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Nervous System Diseases
Physiological Effects of Drugs

Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009