Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
|ClinicalTrials.gov Identifier: NCT01077375|
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : January 26, 2012
Last Update Posted : January 26, 2012
|Study Design||Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment|
|Recruitment Details||Recruitment occurred over an 8 month period from February 2010 to September 2010 at 25 study centers in the United States. Last patient last visit occurred on December 22nd, 2010.|
All participants were given an open-label treatment of duloxetine 60 mg once daily for a two week period before randomization.
Patients randomized to placebo received 1 week of duloxetine 30 mg to effect a duloxetine down-taper. Patients randomized to milnacipran received 1 week of placebo capsules to maintain the blind.