A Randomized, Double-Blind Comparison of Duloxetine 30 mg QD and Placebo in Adult Patients With Fibromyalgia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score
研究概览
简要总结
The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is effective in the treatment of fibromyalgia compared to placebo.
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
- •Meet study criteria for fibromyalgia diagnosis.
排除标准
- •Have previously or are currently taking duloxetine.
- •Have been diagnosed with certain psychoses, bipolar or schizoaffective disorder
- •Have pain symptoms that are difficult to differentiate from fibromyalgia.
- •Have seizure disorder, uncontrolled narrow angle glaucoma, or acute liver injury (such as hepatitis) or severe cirrhosis.
- •Have had any primary Axis 1 diagnosis other than major depressive disorder or generalized anxiety disorder within the past year.
- •Are pregnant or breast-feeding
- •Have a current or previous diagnosis of rheumatoid, infectious or inflammatory arthritis or an autoimmune disease
- •Have a regional pain syndrome, failed back syndrome or chronic localized pan related to any past surgery
- •Have a serious unstable medical illness
- •Have a history of substance abuse or dependence within the past year
研究组 & 干预措施
Duloxetine
干预措施: Duloxetine (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) "24-Hour Average Pain" Item (Question 3) of the BPI-Modified Short Form Score
时间窗: Baseline, 12 weeks
BPI Average Pain score ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Treatment group difference in Least Squares (LS) Means changes from analysis of covariance (ANCOVA) with terms for treatment group, pooled investigators, baseline. Baseline-observation-carried-forward (BOCF) method used to impute endpoint value for those who discontinued initial double-blind therapy (DBT) due to adverse event (AE); last non-missing observation during initial DBT used to impute missing endpoint for all others. Analyses included all participants having non-missing baseline and endpoint.
次要结局
- Change From Baseline to 12-Week Endpoint in the Brief Pain Inventory (BPI) - Modified Short Form(Baseline, 12 weeks)
- Patient Global Impression - Improvement (PGI-I) at Endpoint(12 weeks)
- Clinical Global Impression of Improvement (CGI-I) for Depression at Endpoint(12 weeks)
- Change From Baseline to 12-Week Endpoint Beck Depression Inventory-II (BDI-II)(Baseline, 12 weeks)
- Change From Baseline to 12-Week Endpoint Fibromyalgia Impact Questionnaire (FIQ)(Baseline, 12 weeks)
- Change From Baseline to 12-Week Endpoint Beck Anxiety Inventory (BAI)(Baseline, 12 weeks)
- Change From Baseline to 12-Week Endpoint 36-Item Short-Form Health Survey (SF-36)(Baseline, 12 weeks)
- Number of Participants With Suicidal Behaviors and Ideations Collected by Columbia -Suicide Severity Rating Scale (C-SSRS)(Baseline through 12 weeks)