Duloxetine Versus Placebo in the Treatment of FMS

This study has been completed.
Boehringer Ingelheim
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
First received: October 3, 2005
Last updated: August 22, 2007
Last verified: August 2007
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
Drug: Duloxetine
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Duloxetine 60/120mg Versus Placebo in the Treatment of Fibromyalgia Syndrome

Resource links provided by NLM:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00233025

  Show 34 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim
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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00233025     History of Changes
Other Study ID Numbers: 9072  F1J-MC-HMEF 
Study First Received: October 3, 2005
Last Updated: August 22, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases
Duloxetine Hydrochloride
Antidepressive Agents
Dopamine Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin and Noradrenaline Reuptake Inhibitors

ClinicalTrials.gov processed this record on May 26, 2016