Fibromyalgia Clinical Trial
Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Switch Study to Evaluate the Safety, Tolerability and Efficacy of Milnacipran in Patients With an Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
Verified date | December 2011 |
Source | Forest Laboratories |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 107 |
Est. completion date | January 2011 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Forest Investigative Site 006 | Atlanta | Georgia |
United States | Forest Investigative Site 024 | Atlanta | Georgia |
United States | Forest Investigative Site 017 | Bellevue | Washington |
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 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 015 | Evansville | Indiana |
United States | Forest Investigative Site 011 | Greer | South Carolina |
United States | Forest Investigative Site 010 | Jackson | Mississippi |
United States | Forest Investigative Site 020 | Mechanicsburg | Pennsylvania |
United States | Forest Investigative Site 001 | Medford | Oregon |
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 026 | Racine | Wisconsin |
United States | Forest Investigative Site 013 | Sacramento | California |
United States | Forest Investigative Site 004 | Salt Lake City | Utah |
United States | Forest Investigative Site 025 | St. Louis | Missouri |
United States | Forest Investigative Site 012 | St. Petersburg | Florida |
United States | Forest Investigative Site 014 | Syracuse | New York |
United States | Forest Investigative Site 019 | Tampa | Florida |
United States | Forest Investigative Site 018 | Willingboro | New Jersey |
United States | Forest Investigative Site 005 | Worchester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Forest Laboratories | Cypress Bioscience, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13) | The PGIC is a patient-reported measure of improvement in pain sensation and quality of life scored on a scale from 1 (very much improved) to 7 (very much worse). To meet the criteria for a responder in this study, patients must report a score of 1 (very much improved) or 2 (much improved) on the PGIC. | Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach. | No |
Secondary | Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score | The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain). | Change from Baseline (Week 3) to Visit 5 (Week 13) | No |
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