Fibromyalgia
Conditions
Brief summary
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.
Interventions
DRUGDuloxetine
DRUGPlacebo
Sponsors
Boehringer Ingelheim
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
| evaluate duloxetine 60/120mg (QD) versus placebo during 6-month therapy as measured by the following health outcome measures: | — |
| Percent of patients with 50% improvement in BPI avg. pain score | — |
| BPI Severity | — |
| SF-36 | — |
| EQ-5D | — |
| MFI | — |
| 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 | — |
Countries
Germany, Puerto Rico, Spain, Sweden, United Kingdom, United States
Outcome results
None listed