Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
NCT ID: NCT01077375
Last Updated: 2012-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
107 participants
INTERVENTIONAL
2010-02-28
2011-01-31
Brief Summary
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Detailed Description
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* Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or 10 weeks placebo (one week blinded 30 mg duloxetine)
* One week Double-Blind Down-Taper Period
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo tablets, twice a day, oral administration
Placebo
* Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper.
* Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.
Milnacipran
Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.
Milnacipran
* Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper.
* Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.
Interventions
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Placebo
* Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper.
* Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.
Milnacipran
* Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper.
* Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have been treated with a stable dosage of duloxetine (60 mg/day) for ≥ 4 weeks immediately before Screening (Visit 1)
* Duloxetine must have been prescribed for the treatment of Fibromyalgia
* Have a VAS 1-week pain recall score ≥ 40 mm and ≤ 90 mm
* At Visit 2, to be eligible to enter the randomized treatment period, must continue to have a VAS 1-week pain recall score ≥ 40 mm and be dissatisfied with current Duloxetine treatment.
Exclusion Criteria
* History of mania, bipolar disorder, psychotic disorder, schizophrenia, or a current episode of major depressive disorder
* Myocardial infarction and/or stroke within the prior 6 months
* Systolic blood pressure \> 160 mm Hg or mean diastolic blood pressure \> 100 mm Hg at Screening (Visit 1)
* Substance abuse
* Pulmonary dysfunction
* Severe renal impairment
* Active cardiac disease
* Liver disease
* Uncontrolled narrow-angle glaucoma
* Autoimmune disease
* Cancer
* Inflammatory bowel disease
* Unstable endocrine disease
* Prostatic enlargement
* Female patients who are pregnant or breastfeeding
18 Years
70 Years
ALL
No
Sponsors
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Cypress Bioscience, Inc.
INDUSTRY
Forest Laboratories
INDUSTRY
Responsible Party
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Principal Investigators
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Allan Spera
Role: STUDY_DIRECTOR
Forest Research Institute Inc., A Subsidiary of Forest Laboratories
Locations
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Forest Investigative Site 013
Sacramento, California, United States
Forest Investigative Site 022
Cromwell, Connecticut, United States
Forest Investigative Site 021
Danbury, Connecticut, United States
Forest Investigative Site 007
Delray Beach, Florida, United States
Forest Investigative Site 008
Ocala, Florida, United States
Forest Investigative Site 009
Orlando, Florida, United States
Forest Investigative Site 016
Orlando, Florida, United States
Forest Investigative Site 012
St. Petersburg, Florida, United States
Forest Investigative Site 019
Tampa, Florida, United States
Forest Investigative Site 006
Atlanta, Georgia, United States
Forest Investigative Site 024
Atlanta, Georgia, United States
Forest Investigative Site 015
Evansville, Indiana, United States
Forest Investigative Site 005
Worchester, Massachusetts, United States
Forest Investigative Site 010
Jackson, Mississippi, United States
Forest Investigative Site 025
St Louis, Missouri, United States
Forest Investigative Site 018
Willingboro, New Jersey, United States
Forest Investigative Site 014
Syracuse, New York, United States
Forest Investigative Site 023
Charlotte, North Carolina, United States
Forest Investigative Site 002
Cincinnati, Ohio, United States
Forest Investigative Site 003
Cleveland, Ohio, United States
Forest Investigative Site 001
Medford, Oregon, United States
Forest Investigative Site 020
Mechanicsburg, Pennsylvania, United States
Forest Investigative Site 011
Greer, South Carolina, United States
Forest Investigative Site 004
Salt Lake City, Utah, United States
Forest Investigative Site 017
Bellevue, Washington, United States
Forest Investigative Site 026
Racine, Wisconsin, United States
Countries
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Other Identifiers
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MLN-MD-28
Identifier Type: -
Identifier Source: org_study_id
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