NCT00233025

Brief Summary

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.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2005

Geographic Reach
6 countries

34 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

September 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 3, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

August 23, 2007

Status Verified

August 1, 2007

First QC Date

October 3, 2005

Last Update Submit

August 22, 2007

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (3)

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

  • evaluate change in pain measured by Brief Pain Inventory score

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

Secondary Outcomes (13)

  • change from baseline to endpoint on Sheehan Disability Scale total score

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

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

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

  • FIQ

  • +8 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 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

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.

Birmingham, Alabama, 35294, United States

Location

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Mesa, Arizona, 85210, United States

Location

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Los Angeles, California, 90024, United States

Location

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Pasadena, California, 91106, United States

Location

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Cromwell, Connecticut, 06416, United States

Location

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Stratford, Connecticut, 06615, United States

Location

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Fort Myers, Florida, 33916, United States

Location

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St. Petersburg, Florida, 33709, United States

Location

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Tampa, Florida, 33614, United States

Location

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Evansville, Indiana, 47714, United States

Location

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Columbia, Maryland, 21045, United States

Location

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St Louis, Missouri, 63141, United States

Location

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Oklahoma City, Oklahoma, 73109, United States

Location

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Austin, Texas, 78704, United States

Location

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Waco, Texas, 76708, United States

Location

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Bad Nenndorf, 31542, Germany

Location

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Bad Schönborn, 76669, Germany

Location

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Ellwangen, 73479, Germany

Location

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Göppingen, 73033, Germany

Location

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Itzehoe, 25524, Germany

Location

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Planegg, 82152, Germany

Location

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Stuttgart, 70176, Germany

Location

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Wiesbaden, 65191, Germany

Location

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San Juan, 00918, Puerto Rico

Location

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Barcelona, 08035, Spain

Location

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Madrid, 28028, Spain

Location

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Móstoles, 28935, Spain

Location

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Danderyd, SE-182 88, Sweden

Location

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Linköping, 58185, Sweden

Location

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Mölndal, SE-431 37, Sweden

Location

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Bath, Avon, BA1 1RL, United Kingdom

Location

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Cambridge, Cambridgeshire, CB2 2QB, United Kingdom

Location

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Truro, Cornwall, TR1 3LJ, United Kingdom

Location

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London, SE1 9RT, United Kingdom

Location

Related Publications (1)

  • 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

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

October 3, 2005

First Posted

October 5, 2005

Study Start

September 1, 2005

Study Completion

June 1, 2007

Last Updated

August 23, 2007

Record last verified: 2007-08

Locations

PR(1)US(15)ES(3)SE(3)GB(4)DE(8)