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OpenTrials
Completed

NCT Number: NCT00233025

Duloxetine Versus Placebo in the Treatment of FMS

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.

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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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Bad Nenndorf, Germany

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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 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

Treatment and study plan

Duloxetine

Drug

Placebo

Drug

Primary outcomes

  1. assess efficacy of duloxetine (QD) vs placebo on pain in patients, w/ or w/o MDD during a 6-month therapy phase

  2. evaluate change in pain measured by Brief Pain Inventory score

  3. evaluate endpoint of patient-reported improvement on the Patient's Global Impression of Improvement scale

Secondary outcomes

  1. change from baseline to endpoint on Sheehan Disability Scale total score

  2. assess efficacy of duloxetine vs placebo in first 3-months of therapy measured by change in BPI average score and PGI-I endpoint

  3. evaluate between group differences (duloxetine and placebo) in the first 3-months measured by change in baseline to endpoint in SDS total score

  4. evaluate efficacy of duloxetine versus placebo during 6-month therapy as measured by:

  5. FIQ

  6. CGI-Severity

  7. Tender-point pain thresholds

  8. MFI

  9. Percent of patients with 50% improvement in BPI avg. pain score

  10. BPI Severity

  11. evaluate duloxetine 60/120mg (QD) versus placebo during 6-month therapy as measured by the following health outcome measures:

  12. SF-36

  13. EQ-5D

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Official study title

Duloxetine 60/120mg Versus Placebo in the Treatment of Fibromyalgia Syndrome

Important dates

Study start
2005
Study completion
2007
First posted
Oct 5, 2005
Registry last updated
Aug 23, 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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