Dose Response Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

Eli Lilly and Company3 sites in 2 countries210 target enrollmentJune 2005

ConditionsFibromyalgia

DrugsDuloxetine placebo

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: Eli Lilly and Company
Enrollment: 210
Locations: 3
Primary Endpoint: Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2005

End Date

June 2007

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome

Secondary Outcomes

Sheehan Disability Scale total score
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
Quality of life
Effect duloxetine on pain is independent of MDD or mood improvement
Assess safety of duloxetine