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Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia - NCT01077375-30328B(Clinical Trial 564209)



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City:  Atlanta
State:  
GA
Zip Code: 30328
Conditions: Fibromyalgia
Purpose: The objective of this study is to evaluate the safety, tolerability and efficacy of milnacipran in patients with an inadequate response to duloxetine for the treatment of fibromyalgia.
Study summary: - Two weeks Duloxetine 60 mg Open-Label Period - 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
Criteria: Inclusion Criteria: - Diagnosis of fibromyalgia - 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: - Suicidal risk - 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
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Data Source: ClinicalTrials.gov
Date Processed: September 22, 2010
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