NCT00673452已完成4 期
Flexible Dosed Duloxetine Versus Placebo in the Treatment of Fibromyalgia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- Patient's Global Impressions of Improvement (PGI-I) at Week 12
研究概览
简要总结
The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older. Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female patients
- •aged 18 and older who meet criteria for fibromyalgia as defined by the American College of Rheumatology
- •have a score of at least 4 on the average pain item of the Brief Pain Inventory (BPI) (modified short form) at visits 1 and 2
- •all females must test negative for pregnancy at the time of enrollment
- •have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.
排除标准
- •have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
- •have regional pain syndrome, multiple surgeries or failed back syndrome
- •have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)
研究组 & 干预措施
Duloxetine
Experimental
60-120 mg, oral, every day, 12 weeks
干预措施: duloxetine hydrochloride (Drug)
Placebo
Placebo Comparator
oral, daily, 12 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Patient's Global Impressions of Improvement (PGI-I) at Week 12
时间窗: 12 weeks
The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms. It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse."
次要结局
- Change From Baseline in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint(Baseline, 12 weeks)
- Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint(Baseline, 12 weeks)
- Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint(Baseline, 12 weeks)
- Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint(Baseline, 12 Weeks)
- Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint(Baseline, 12 weeks)
- Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks(Baseline, 12 weeks)
- Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint(Baseline, 12 weeks)
- Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint(Baseline, 12 weeks)
- Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint(12 Weeks)
- Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint(12 weeks)
- Change From Baseline in Blood Pressure at 12 Week Endpoint(Baseline, 12 weeks)
- Change From Baseline in Heart Rate at 12 Week Endpoint(Baseline, 12 weeks)
- Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts)(Baseline through 12 Weeks)
- Change From Baseline in Weight at 12 Week Endpoint(Baseline, 12 weeks)
研究者
研究点 (1)
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