Protocol F1J-MC-HMEO Duloxetine Versus Placebo in the Treatment of Chronic Low Back Pain
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 404
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 1 in Weekly Mean of the 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.
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.
排除标准
- •You have a serious or unstable disease 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, or 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
- •Have major depressive disorder. - Require daily narcotics.
研究组 & 干预措施
Duloxetine 20 mg
duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
干预措施: Duloxetine (Drug)
Duloxetine 60 mg
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
干预措施: Duloxetine (Drug)
Duloxetine 120 mg
duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
干预措施: Duloxetine (Drug)
Placebo
placebo once a day (QD), by mouth (PO) for 13 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Week 1 in Weekly Mean of the 24-hour Average Pain Scores
时间窗: Baseline, Week 1
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Change From Baseline to Week 2 in Weekly Mean of the 24-Hour Average Pain Scores
时间窗: Baseline, Week 2
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 2), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Change From Baseline to Week 3 in Weekly Mean of the 24-Hour Average Pain Scores
时间窗: Baseline, Week 3
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 3), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Change From Baseline to Week 4 in Weekly Mean of the 24-Hour Average Pain Scores
时间窗: Baseline, Week 4
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 4), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Change From Baseline to Week 5 in Weekly Mean of the 24-Hour Average Pain Scores
时间窗: Baseline, Week 5
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 5), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Change From Baseline to Week 6 in Weekly Mean of the 24-Hour Average Pain Scores
时间窗: Baseline, Week 6
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 6), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Change From Baseline to Week 7 in Weekly Mean of the 24-Hour Average Pain Scores
时间窗: Baseline, Week 7
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 7), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Change From Baseline to Week 8 in Weekly Mean of the 24-Hour Average Pain Scores
时间窗: Baseline, Week 8
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 8), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Change From Baseline to Week 9 in Weekly Mean of the 24-Hour Average Pain Scores
时间窗: Baseline, Week 9
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 1), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Change From Baseline to Week 10 in Weekly Mean of the 24-Hour Average Pain Scores
时间窗: Baseline, Week 10
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 10), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Change From Baseline to Week 11 in Weekly Mean of the 24-Hour Average Pain Scores
时间窗: Baseline, Week 11
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 11), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Change From Baseline to Week 12 in Weekly Mean of the 24-Hour Average Pain Scores
时间窗: Baseline, Week 12
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 12), with scores ranging from 0 (no pain) to 10 (worst possible pain).
Change From Baseline to Week 13 Endpoint in Weekly Mean of the 24-Hour Average Pain Scores
时间窗: Baseline, Week 13
24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean (Week 13), with scores ranging from 0 (no pain) to 10 (worst possible pain).
次要结局
- Patient's Global Impression - Improvement (PGI-I) at Week 13 Endpoint(Week 13)
- Change From Baseline to Week 13 Endpoint in Roland-Morris Disability Questionnaire (RMDQ) Total Score(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean 24-Hour Night Pain Score(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in the 11-point Likert Scale, Weekly Mean of Worst Pain Score(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Clinical Global Impression of Severity(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Worst Pain Score(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Least Pain Score(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Average Pain Score(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Severity (BPI-S) - Pain Right Now Score(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - General Activity(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Mood(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Walking Ability(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Normal Work(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Relations With Other People(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Sleep(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Enjoyment of Life(Baseline, Week 13)
- Response to Treatment, as Defined by a 50% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward(Baseline to Week 13)
- Change From Baseline to Week 13 Endpoint in Brief Pain Inventory Interference (BPI-I) Score - Average Interference(Baseline, Week 13)
- Response to Treatment, as Defined by a 30% Reduction of Weekly Mean Score in 24-hour Average Pain Severity Ratings, Last Observation Carried Forward(Baseline to Week 13)
- Change From Baseline to Week 13 Endpoint in Athens Insomnia Scale(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in the 36-item Short-Form Health Survey (SF36)- Mental Component Summary (MCS)(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Component Summary (PCS)(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Bodily Pain(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - General Health(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Mental Health(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Physical Functioning(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Emotional(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Role-Physical(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Social Functioning(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF36) - Vitality(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in the Euro-Quality of Life Questionnaire - 5 Dimension - US Based Index Score(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Beck Depression Inventory-II Total Score(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale(Baseline, Week 13)
- Adverse Events Reported as Reason for Discontinuation(Baseline to Week 13)
- Change From Baseline to Week 13 Endpoint in Laboratory Assessments - Alkaline Phosphatase(Baseline, Week 13)
- Change From Baseline to 13 Week Endpoint in Laboratory Assessments - Alanine Transaminase(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bicarbonate, HCO3(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Direct(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Bilirubin, Total(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Chloride(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Cholesterol(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Creatinine(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Potassium(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Laboratory Assessment - Uric Acid(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Vital Signs - Pulse Rate(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Vital Signs - Systolic Blood Pressure(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Vital Signs - Diastolic Blood Pressure(Baseline, Week 13)
- Change From Baseline to Week 13 Endpoint in Vital Signs - Weight(Baseline, Week 13)