Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores
研究概览
简要总结
The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition.
Whether duloxetine once daily can help patients with Chronic Low Back Pain.
Patients who do not have their pain reduced by at least 30% by week 7 will be given 120 mg dose for the duration of the study. After the 13 week double blind period, patients randomized to placebo will switch to duloxetine 60 mg or 120 mg in the 41-week extension period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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/Female outpatients 18 years of age with chronic low back pain
- •Females of child bearing potential must test negative on a pregnancy test at visit 1.
排除标准
- •Have a serious or unstable diseases of the heart or blood vessels, liver, kidney, lungs, or blood-related illness
- •Problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions
- •Psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study
- •Have acute liver injury (such as hepatitis) or severe cirrhosis
- •Have had previous exposure to duloxetine
- •Have a body mass index (BMI) over 40
- •Have a major depressive disorder
- •Require daily narcotics
- •Have suicidal risk
- •Have a presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures
研究组 & 干预措施
Duloxetine
30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
干预措施: Duloxetine (Drug)
Placebo
every day (QD), by mouth (PO), 13 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores
时间窗: Baseline, Week 13
A self-reported scale that measures the severity of pain based on the average pain over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
次要结局
- Patient's Global Impression of Improvement (PGI-I)(Week 13)
- Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score(Baseline, Week 13, Week 54)
- Change From Baseline to Week 13 Endpoint in Weekly Mean of 24-hour Average Pain, Night Pain and Worst Pain by 11-Point Likert Scale(Baseline, Week 13)
- Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores(Baseline, Week 13, Week 54)
- Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)(Baseline, Week 13, Week 54)
- Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria(Week 13)
- Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria(Week 13)
- Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale(Baseline, Week 13, Week 54)
- Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)(Baseline, Week 13)
- Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores(Baseline, Week 13, Week 54)
- Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores(Baseline, Week 13, Week 54)
- Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores(Baseline, Week 13)
- Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate(Baseline, Week 13)
- Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid(Baseline, Week 13)
- Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate(Baseline, Week 13, Week 54)
- Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure(Baseline, Week 13, Week 54)
- Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight(Baseline, Week 13, Week 54)