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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 26
- 主要终点
- Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)
研究概览
简要总结
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.
详细描述
- 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
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •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.
排除标准
- •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
- •Inflammatory bowel disease
- •Unstable endocrine disease
- •Prostatic enlargement
- •Female patients who are pregnant or breastfeeding
研究组 & 干预措施
Placebo
Placebo tablets, twice a day, oral administration
干预措施: Placebo (Drug)
Milnacipran
Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses.
干预措施: Milnacipran (Drug)
结局指标
主要结局
Responder Status Based on Patient Global Impression of Change (PGIC) Score at Visit 5 (Week 13)
时间窗: 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.
次要结局
- Change From Baseline to Visit 5 (Week 13) in the Visual Analog Scale (VAS) 1-week Pain Recall Score(Change from Baseline (Week 3) to Visit 5 (Week 13))