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Completed

NCT Number: NCT00190866

Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Ponce, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Duloxetine

Drug

Placebo

Drug

Primary outcomes

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

Secondary outcomes

  1. Sheehan Disability Scale total score

  2. Average pain item of the BPI and the endpoint of the PGI-Improvement

  3. Reduction of pain severity

  4. 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

  5. Quality of life

  6. Effect duloxetine on pain is independent of MDD or mood improvement

  7. Assess safety of duloxetine

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Nov 6, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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