Study of Milnacipran for the Treatment of Fibromyalgia

NCT ID: NCT00314249

Last Updated: 2010-01-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1025 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Brief Summary

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The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.

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

Participants Investigators

Study Groups

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Placebo

Placebo, oral administration, twice daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo, oral administration, twice daily for 12 weeks

Milnacipran

Milnacipran 100mg/day (50mg BID \[twice a day\])

Group Type EXPERIMENTAL

Milnacipran 100mg

Intervention Type DRUG

Milnacipran 100mg per day (50mg BID \[twice a day\])

Interventions

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Placebo

Placebo, oral administration, twice daily for 12 weeks

Intervention Type DRUG

Milnacipran 100mg

Milnacipran 100mg per day (50mg BID \[twice a day\])

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,
* 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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Cypress Bioscience, Inc.

INDUSTRY

Sponsor Role collaborator

Forest Laboratories

INDUSTRY

Sponsor Role lead

Responsible Party

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Forest Research Institute, a subsidiary of Forest Laboratories, Inc.

Locations

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Forest Investigative Site

Tuscaloosa, Alabama, United States

Site Status

Forest Investigative Site

Fresno, California, United States

Site Status

Forest Investigative Site

Pismo Beach, California, United States

Site Status

Forest Investigative Site

Vista, California, United States

Site Status

Forest Investigative Site

St. Petersburg, Florida, United States

Site Status

Forest Investigative Site

St. Petersburg, Florida, United States

Site Status

Forest Investigative Site

Stuart, Florida, United States

Site Status

Forest Investigative Site

Atlanta, Georgia, United States

Site Status

Forest Investigative Site

Springfield, Massachusetts, United States

Site Status

Forest Investigative Site

Worcester, Massachusetts, United States

Site Status

Forest Investigative Site

Omaha, Nebraska, United States

Site Status

Forest Investigative Site

Haddon Heights, New Jersey, United States

Site Status

Forest Investigative Site

Johnson City, New York, United States

Site Status

Forest Investigative Site

Syracuse, New York, United States

Site Status

Forest Investigative Site

Greensboro, North Carolina, United States

Site Status

Forest Investigative Site

Cleveland, Ohio, United States

Site Status

Forest Investigative Site

Columbus, Ohio, United States

Site Status

Forest Investigative Site

Toledo, Ohio, United States

Site Status

Forest Investigative Site

Eugene, Oregon, United States

Site Status

Forest Investigative Site

Mechanicsburg, Pennsylvania, United States

Site Status

Forest Investigative Site

Anderson, South Carolina, United States

Site Status

Forest Investigative Site

Greer, South Carolina, United States

Site Status

Forest Investigative Site

Richardson, Texas, United States

Site Status

Forest Investigative Site

Virginia Beach, Virginia, United States

Site Status

Countries

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United States

References

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Saxe PA, Arnold LM, Palmer RH, Gendreau RM, Chen W. Short-term (2-week) effects of discontinuing milnacipran in patients with fibromyalgia. Curr Med Res Opin. 2012 May;28(5):815-21. doi: 10.1185/03007995.2012.677418. Epub 2012 Apr 10.

Reference Type DERIVED
PMID: 22429066 (View on PubMed)

Arnold LM, Gendreau RM, Palmer RH, Gendreau JF, Wang Y. Efficacy and safety of milnacipran 100 mg/day in patients with fibromyalgia: results of a randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2010 Sep;62(9):2745-56. doi: 10.1002/art.27559.

Reference Type DERIVED
PMID: 20496365 (View on PubMed)

Other Identifiers

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MLN-MD-03

Identifier Type: -

Identifier Source: org_study_id

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