Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
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|ClinicalTrials.gov Identifier: NCT01077375|
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : January 26, 2012
Last Update Posted : January 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Drug: Placebo Drug: Milnacipran||Phase 4|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||January 2011|
Placebo Comparator: Placebo
Placebo tablets, twice a day, oral administration
Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.
Other Name: Savella
- Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13) [ Time Frame: Assessed at Visit 4 (Week 9) and Visit 5 (Week 13) or early termination. Presented results generated via LOCF approach. ]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.
- Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score [ Time Frame: Change from Baseline (Week 3) to Visit 5 (Week 13) ]The VAS assessment ranges from a scale of 0 (no pain) to 100 (worst possible pain).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077375
Show 26 Study Locations
|Study Director:||Allan Spera||Forest Research Institute Inc., A Subsidiary of Forest Laboratories|