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Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00190866
First received: September 12, 2005
Last updated: November 5, 2007
Last verified: November 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
 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: Dose Response Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 210
Study Start Date: June 2005
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190866

  Show 35 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Boehringer Ingelheim Pharmaceuticals
Investigators
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:
Lilly Clinical Trial Registry  This link exits the ClinicalTrials.gov site

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00190866     History of Changes
Other Study ID Numbers: 6222, F1J-MC-HMCJ
Study First Received: September 12, 2005
Last Updated: November 5, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013