Clinical Trial: Study of Milnacipran for the Treatment of Fibromyalgia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
Brief Summary: The purpose of this study was to demonstrate the efficacy and safety of milnacipran at a dosage of 100 mg/day in the treatment of the fibromyalgia syndrome or the pain associate with fibromyalgia.
Detailed Summary:
Sponsor: Forest Laboratories
Current Primary Outcome:
- Composite Syndrome Responder Status [ Time Frame: At the end of the three-month stable dose treatment phase ]
- Composite Pain Responder Status [ Time Frame: At the end of three-month stable dose treatment phase ]
Original Primary Outcome: Composite responder analysis based on pain, patient global status, and physical function.
Current Secondary Outcome:
- Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase [ Time Frame: Weeks 1 through 12 of the stable dose treatment phase (Visit TX0-TX12) ]
- Time-Weighted Average of Patient Global Impression of Change (PGIC) From Visit TX0-TX12. [ Time Frame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase ]
- Change From Baseline in the Multi-Dimensional Fatigue Inventory (MFI) Total Score at Visit TX12. [ Time Frame: Baseline through end of week 12 (Visit TX12) ]
- Time-Weighted Average of the Short Form-36 Physical Component Summary (SF-36 PCS) Score From Visit TX0-TX12 [ Time Frame: Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase ]
Original Secondary Outcome: Quality of Life; Health Status Assessment; Fatigue, anxiety and cognitive assessments
Information By: Forest Laboratories
Dates:
Date Received: April 11, 2006
Date Started: April 2006
Date Completion:
Last Updated: January 14, 2010
Last Verified: January 2010
