Study of Milnacipran for the Treatment of Fibromyalgia

NCT ID: NCT00098124

Last Updated: 2007-12-24

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

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-12-31

Brief Summary

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Antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. The majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. Milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.

Detailed Description

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Conditions

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Fibromyalgia

Keywords

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NSRI milnacipran 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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milnacipran hydrochloride

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria

Exclusion Criteria

* Psychiatric illness
* Depression
* Suicidal risk
* Substance abuse
* Pulmonary dysfunction
* Renal impairment
* Active cardiac disease
* Liver disease
* Autoimmune disease
* Cancer
* Sleep apnea
* Inflammatory bowel disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role lead

Locations

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Forest Investigative Site

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Montgomery, Alabama, United States

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Peoria, Arizona, United States

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Beverly Hills, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Spring Valley, California, United States

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Torrance, California, United States

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Colorado Springs, Colorado, United States

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Colorado Springs, Colorado, United States

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Danbury, Connecticut, United States

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Stamford, Connecticut, United States

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Trumball, Connecticut, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Delray Beach, Florida, United States

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Jacksonville, Florida, United States

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Ocala, Florida, United States

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Ormond Beach, Florida, United States

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Palm Harbor, Florida, United States

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Pembroke Pines, Florida, United States

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Port Orange, Florida, United States

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Tamarac, Florida, United States

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Decatur, Georgia, United States

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Honolulu, Hawaii, United States

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Meridian, Idaho, United States

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Chicago, Illinois, United States

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Libertyville, Illinois, United States

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Peoria, Illinois, United States

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Evansville, Indiana, United States

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Lafayette, Indiana, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Frederick, Maryland, United States

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Newton, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Kalamazoo, Michigan, United States

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Flowood, Mississippi, United States

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St Louis, Missouri, United States

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Missoula, Montana, United States

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Cherry Hill, New Jersey, United States

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Clementon, New Jersey, United States

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Santa Fe, New Mexico, United States

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East Syracuse, New York, United States

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Great Neck, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Fayetteville, North Carolina, United States

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Hickory, North Carolina, United States

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Raleigh, North Carolina, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Marion, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Bend, Oregon, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Duncanville, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Orangeburg, South Carolina, United States

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Bristol, Tennessee, United States

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Chattanooga, Tennessee, United States

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Memphis, Tennessee, United States

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Austin, Texas, United States

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San Antonio, Texas, United States

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Sugarland, Texas, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Bellingham, Washington, United States

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Everett, Washington, United States

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Seattle, Washington, United States

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Wenatchee, Washington, United States

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Racine, Wisconsin, United States

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Countries

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United States

References

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Clauw DJ, Mease P, Palmer RH, Gendreau RM, Wang Y. Milnacipran for the treatment of fibromyalgia in adults: a 15-week, multicenter, randomized, double-blind, placebo-controlled, multiple-dose clinical trial. Clin Ther. 2008 Nov;30(11):1988-2004. doi: 10.1016/j.clinthera.2008.11.009.

Reference Type DERIVED
PMID: 19108787 (View on PubMed)

Other Identifiers

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MLN-MD-02

Identifier Type: -

Identifier Source: org_study_id