Duloxetine Versus Placebo in the Treatment of FMS

Eli Lilly and Company320 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

320

Conditions

Fibromyalgia

Interventions

DuloxetineDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (34)

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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Birmingham, Alabama, United States

Mesa, Arizona, United States

Los Angeles, California, United States

Pasadena, California, United States

Cromwell, Connecticut, United States

Stratford, Connecticut, United States

Fort Myers, Florida, United States

St. Petersburg, Florida, United States

Tampa, Florida, United States

Evansville, Indiana, United States

...and 24 more locations