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Duloxetine Versus Placebo in Chronic Low Back Pain

2009年11月18日 更新者：Eli Lilly and Company

Effect of Duloxetine 60 mg to 120 mg Once Daily in Patients With Chronic Low Back Pain

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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

236

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 墨西哥
      • Mexico City、墨西哥、06700
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Monterrey、墨西哥、64460
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • San Pedro Garza Garcia、墨西哥、66260
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
  • 巴西
      • Curitiba、巴西、80060240
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • San Paulo、巴西、04027-000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Sao Paulo、巴西、04026-000
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
  • 德国
      • Ellwangen、德国、73479
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Graefelfing、德国、82166
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Hamburg、德国、22143
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Wiesbaden、德国、65191
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
  • 法国
      • Amiens、法国、80054
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Marseille、法国、13008
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Paris、法国、75014
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Saint Affrique、法国、12400
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Saint-Etienne、法国、42055
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
  • 荷兰
      • Amsterdam、荷兰、1105 AZ
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p
      • Rotterdam、荷兰、3039 BD
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your p

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：单组作业
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：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
药品：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
其他名称：
  • 欣百达
  • LY248686
安慰剂比较：Placebo
every day (QD), by mouth (PO), 13 weeks
药品：Placebo
every day (QD), by mouth (PO), 13 weeks

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores
大体时间：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).
Baseline, Week 13

次要结果测量

结果测量
措施说明
大体时间
Patient's Global Impression of Improvement (PGI-I)
大体时间：Week 13
A scale that measures the patient's perception of improvement at the time of assessment. The score ranges from 1 (very much better) to 7 (very much worse).
Week 13
Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score
大体时间：Baseline, Week 13, Week 54
Roland-Morris questionnaire will be completed by the patient and measures the degree of disability due to back pain. The questionnaire consists of 24 statements and the patient is instructed to put a mark next to each appropriate statement. The number of statements marked will be added up by the clinician and a total score is given. The total score ranges from 0 (no disability) to 24 (severe disability).
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
大体时间：Baseline, Week 13
24-hour average pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Patients should complete the electronic diary at bedtime. The 11-point Likert scale will also be used for assessment of night pain and worst pain each day, and evaluated as weekly means. Average interference was calculated as the average of non-missing scores of individual interference items.
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
大体时间：Baseline, Week 13, Week 54
BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.
Baseline, Week 13, Week 54
Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)
大体时间：Baseline, Week 13, Week 54
Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Baseline, Week 13, Week 54
Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria
大体时间：Week 13
Response to treatment was defined as at least a 30% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.
Week 13
Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria
大体时间：Week 13
Response to treatment was defined as at least a 50% reduction of weekly mean score in in Brief Pain Inventory (BPI) Average Pain severity ratings from baseline to endpoint. The number of participants who met this criteria are presented.
Week 13
Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale
大体时间：Baseline, Week 13, Week 54
Estimates sleep difficulty. Consists of 8 items rated on a 4-point scale of 0 (no problem at all) to 3 (very serious problem). Total score of the 8-item version ranges from 0-24.
Baseline, Week 13, Week 54
Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
大体时间：Baseline, Week 13
The SF-36 Health Status Survey is a generic, health-related scale assessing subjects' quality of life on 8 domains: physical functioning, social functioning, bodily pain, vitality, mental health, role-physical, role-emotional and general health and 2 summary scores (mental component summary [MCS] and physical component summary [PCS]). MCS and PCS scores=0-100 (higher scores indicate better health status). Domain scores: general health=5-25; physical functioning=10-30; role-physical=4-8; role-emotional=3-6; social functioning=2-10; bodily pain=2-11; vitality=4-24; mental health=5-30.
Baseline, Week 13
Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)
大体时间：Baseline, Week 13
The EuroQoL Questionnaire - 5 Dimension (EQ-5D) is a generic, multidimensional, health-related, quality-of-life instrument. The profile allows patients to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each patient, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the patient. Scores presented used the UK Based Index Score.
Baseline, Week 13
Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
大体时间：Baseline, Week 13, Week 54

WPAI: self-administered instrument used to measure effect of general health and symptom severity on work productivity and regular activities and yields 4 types of scores: Absenteeism (work time missed); Presenteeism (impairment at work/reduced on-the-job effectiveness); Work Productivity Loss (overall work impairment/absenteeism plus presenteeism); and Activity Impairment. Higher scores are indicative of greater impairment.

  1. Absenteeism=(Q2/(Q2+Q4))*100
  2. Presenteeism=(Q5/10)*100
  3. Work productivity loss=(Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)])*100
  4. Activity Impairment=(Q6/10)*100
Baseline, Week 13, Week 54
Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores
大体时间：Baseline, Week 13, Week 54
A 21-item, patient-completed questionnaire to assess characteristics of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score. There is a four-point scale for each item ranging from 0 to 3. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Baseline, Week 13, Week 54
Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores
大体时间：Baseline, Week 13
A 14-item questionnaire with 2 subscales: anxiety and depression. Each item is rated on a 4-point scale, giving maximum scores of 21 for anxiety and depression. Scores of 11 or more on either subscale are considered to be a significant 'case' of psychological morbidity, while scores of 8-10 represent 'borderline' and 0-7, 'normal.'
Baseline, Week 13
Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate
大体时间：Baseline, Week 13
Baseline, Week 13
Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid
大体时间：Baseline, Week 13
Baseline, Week 13
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate
大体时间：Baseline, Week 13, Week 54
Baseline, Week 13, Week 54
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure
大体时间：Baseline, Week 13, Week 54
Baseline, Week 13, Week 54
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight
大体时间：Baseline, Week 13, Week 54
Baseline, Week 13, Week 54

其他结果措施

结果测量
措施说明
大体时间
Serious Adverse Events During the Dose-Blind Extension Phase
大体时间：Week 13 though Week 54
Serious adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.
Week 13 though Week 54
Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase
大体时间：Week 13 through Week 54
Treatment-emergent adverse events during the extension phase reported based on the original treatment group to which the patient was randomized. Dictionary used was MedDRA 11.0.
Week 13 through Week 54

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eli Lilly and Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年1月1日

初级完成 (实际的)

2007年12月1日

研究完成 (实际的)

2008年10月1日

研究注册日期

首次提交

2007年1月17日

首先提交符合 QC 标准的

2007年1月17日

首次发布 (估计)

2007年1月19日

研究记录更新

最后更新发布 (估计)

2009年11月20日

上次提交的符合 QC 标准的更新

2009年11月18日

最后验证

2009年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 10544 (其他标识符：Fred Hutch/University of Washington Cancer Consortium)
  • F1J-MC-HMEN

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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