Fibromyalgia
Conditions
Brief summary
To assess the efficacy of Duloxetine compared with placebo in the treatment of pain in patients with Fibromyalgia syndrome, with or without major depressive disorder.
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 for primary Fibromyalgia Syndrome as defined by the American College of Rheumatology
Exclusion criteria
* Have any current primary Axis I diagnosis other than major depressive disorder * Have any current or previous diagnosis of psychosis, bipolar disorder, or schizoaffective disorder * Have any primary diagnosis of anxiety disorder within the past year (including panic disorder, agoraphobia, OCD, PTSD, GAD and social phobia) * Have regional pain syndrome, multiple surgeries or failed back syndrome * Have a confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infective arthritis, or an autoimmune disease (e.g. lupus)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome | — |
Secondary
| Measure | Time frame |
|---|---|
| Average pain item of the BPI and the endpoint of the PGI-Improvement | — |
| Reduction of pain severity | — |
| Evaluate efficacy through the following: Fibromyalgia Impact Questionnaire, CGI-Severity, Tender-point pain thresholds, Multidimensional Fatigue Inventory, BPI average pain score, BPI severity and Interference scores | — |
| Sheehan Disability Scale total score | — |
| Effect duloxetine on pain is independent of MDD or mood improvement | — |
| Assess safety of duloxetine | — |
| Quality of life | — |
Countries
Puerto Rico, United States
Outcome results
None listed