NCT00190866

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2005

Geographic Reach
2 countries

35 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

November 6, 2007

Status Verified

November 1, 2007

First QC Date

September 12, 2005

Last Update Submit

November 5, 2007

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Interventions

DuloxetineDRUG
placeboDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet criteria for primary Fibromyalgia Syndrome as defined by the American College of Rheumatology

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (35)

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.

Peoria, Arizona, United States

Location

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Phoenix, Arizona, United States

Location

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Tucson, Arizona, United States

Location

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Burbank, California, United States

Location

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Sherman Oaks, California, United States

Location

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Walnut Creek, California, United States

Location

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Danbury, Connecticut, United States

Location

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DeLand, Florida, United States

Location

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Fort Myers, Florida, United States

Location

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Miami, Florida, United States

Location

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Lafayette, Indiana, United States

Location

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Prairie Village, Kansas, United States

Location

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Fall River, Massachusetts, United States

Location

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Springfield, Massachusetts, United States

Location

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St Louis, Missouri, United States

Location

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Albany, New York, United States

Location

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Greensboro, North Carolina, United States

Location

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Cincinnati, Ohio, United States

Location

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Cleveland, Ohio, United States

Location

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Toledo, Ohio, United States

Location

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Eugene, Oregon, United States

Location

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Portland, Oregon, United States

Location

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Philadelphia, Pennsylvania, United States

Location

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Wyomissing, Pennsylvania, United States

Location

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Cranston, Rhode Island, United States

Location

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Mt. Pleasant, South Carolina, United States

Location

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Myrtle Beach, South Carolina, United States

Location

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Austin, Texas, United States

Location

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Lake Jackson, Texas, United States

Location

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San Antonio, Texas, United States

Location

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Woodstock, Vermont, United States

Location

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Kirkland, Washington, United States

Location

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Seattle, Washington, United States

Location

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Ponce, Puerto Rico

Location

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San Juan, Puerto Rico

Location

Related Publications (2)

  • Mease PJ, Spaeth M, Clauw DJ, Arnold LM, Bradley LA, Russell IJ, Kajdasz DK, Walker DJ, Chappell AS. Estimation of minimum clinically important difference for pain in fibromyalgia. Arthritis Care Res (Hoboken). 2011 Jun;63(6):821-6. doi: 10.1002/acr.20449.

    PMID: 21312349DERIVED

  • Russell JI, Mease PJ, Smith TR, Kajdasz DK, Wohlreich MM, Detke MJ, Walker DJ, Chappell AS, Arnold LM. Efficacy and safety of duloxetine for treatment of fibromyalgia in patients with or without major depressive disorder: Results from a 6-month, randomized, double-blind, placebo-controlled, fixed-dose trial. Pain. 2008 Jun;136(3):432-444. doi: 10.1016/j.pain.2008.02.024. Epub 2008 Apr 18.

    PMID: 18395345DERIVED

Related Links

MeSH Terms

Conditions

Fibromyalgia

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

June 1, 2005

Study Completion

June 1, 2007

Last Updated

November 6, 2007

Record last verified: 2007-11

Locations

PR(2)US(33)