A Phase III Pivotal, Multicenter, Double-blind, Randomized, Placebo-Controlled Monotherapy Study of Milnacipran for the Treatment of Fibromyalgia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,025
- 试验地点
- 1
- 主要终点
- Composite Syndrome Responder Status
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of fibromyalgia defined by 1990 American College of Rheumatology (ACR) Criteria
排除标准
- •psychiatric illness,
- •depression,
- •suicidal risk,
- •substance abuse,
- •pulmonary dysfunction,
- •renal impairment,
- •active cardiac disease,
- •liver disease,
- •autoimmune disease,
- •inflammatory bowel disease
研究组 & 干预措施
Placebo
Placebo, oral administration, twice daily for 12 weeks
干预措施: Placebo (Drug)
Milnacipran
Milnacipran 100mg/day (50mg BID [twice a day])
干预措施: Milnacipran 100mg (Drug)
结局指标
主要结局
Composite Syndrome Responder Status
时间窗: At the end of the three-month stable dose treatment phase
Composite Syndrome Responder Status is the number of responders based on 3 domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary \[PED\], electronic diary, during the morning report; 24 hour recall); (2) patient global impression of change (PGIC) score of "very much improved" and "much improved;" and (3) physical function improvement of 6 or more points on Short Form-36 Physical Component Summary (SF-36 PCS)
Composite Pain Responder Status
时间窗: At the end of three-month stable dose treatment phase
Composite Pain Responder Status is the number of responders based on two domains: (1) 30% reduction in pain (as recorded in the Patient Experience Diary \[PED\], electronic diary, during the morning report; 24 hour recall); and (2) Patient Global Impression of Change (PGIC) score of "very much improved" or "much improved."
次要结局
- Time-Weighted Average of Patient Experience Diary (PED) Reported Morning 24-Hour Recall Pain Scores for Weeks 1-12 of the Stable Dose Phase(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.(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.(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(Weeks 1-12 (Visit TX0-TX12) of the stable dose treatment phase)