Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome

This study has been completed.
Sponsor:
Collaborator:
Boehringer Ingelheim
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

September 12, 2005
November 5, 2007
June 2005
Not Provided
Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
-Assess efficacy of duloxetine versus placebo on the treatment of pain in patients with fibromyalgia syndrome
Complete list of historical versions of study NCT00190866 on ClinicalTrials.gov Archive Site
  • 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
  • -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
Not Provided
Not Provided
 
Study of Duloxetine Versus Placebo in the Treatment of Fibromyalgia Syndrome
Dose Response 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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Fibromyalgia
  • Drug: Duloxetine
  • Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
210
June 2007
Not Provided

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00190866
6222, F1J-MC-HMCJ
Not Provided
Not Provided
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
Eli Lilly and Company
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP