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Duloxetine Versus Placebo in the Treatment of FMS

NCT ID: NCT00233025

Last Updated: 2007-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Duloxetine

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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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, United States

Site Status

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.

Mesa, Arizona, United States

Site Status

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Los Angeles, California, United States

Site Status

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Pasadena, California, United States

Site Status

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Cromwell, Connecticut, United States

Site Status

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Stratford, Connecticut, United States

Site Status

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Fort Myers, Florida, United States

Site Status

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St. Petersburg, Florida, United States

Site Status

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Tampa, Florida, United States

Site Status

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Evansville, Indiana, United States

Site Status

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Columbia, Maryland, United States

Site Status

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St Louis, Missouri, United States

Site Status

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Oklahoma City, Oklahoma, United States

Site Status

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Austin, Texas, United States

Site Status

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Waco, Texas, United States

Site Status

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Bad Nenndorf, , Germany

Site Status

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Bad Schönborn, , Germany

Site Status

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Ellwangen, , Germany

Site Status

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Göppingen, , Germany

Site Status

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Itzehoe, , Germany

Site Status

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Planegg, , Germany

Site Status

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Stuttgart, , Germany

Site Status

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Wiesbaden, , Germany

Site Status

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San Juan, , Puerto Rico

Site Status

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Barcelona, , Spain

Site Status

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Madrid, , Spain

Site Status

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Móstoles, , Spain

Site Status

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Danderyd, , Sweden

Site Status

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Linköping, , Sweden

Site Status

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Mölndal, , Sweden

Site Status

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Bath, Avon, United Kingdom

Site Status

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Cambridge, Cambridgeshire, United Kingdom

Site Status

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.

Truro, Cornwall, United Kingdom

Site Status

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London, , United Kingdom

Site Status

Countries

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United States Germany Puerto Rico Spain Sweden United Kingdom

References

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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.

Reference Type DERIVED
PMID: 21312349 (View on PubMed)

Other Identifiers

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F1J-MC-HMEF

Identifier Type: -

Identifier Source: secondary_id

9072

Identifier Type: -

Identifier Source: org_study_id