Duloxetine Versus Placebo in Chronic Low Back Pain
2009년 11월 18일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
236
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Amsterdam, 네덜란드, 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
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Rotterdam, 네덜란드, 3039 BD
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Ellwangen, 독일, 73479
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Graefelfing, 독일, 82166
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Hamburg, 독일, 22143
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Wiesbaden, 독일, 65191
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Mexico City, 멕시코, 06700
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Monterrey, 멕시코, 64460
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San Pedro Garza Garcia, 멕시코, 66260
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Curitiba, 브라질, 80060240
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San Paulo, 브라질, 04027-000
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Sao Paulo, 브라질, 04026-000
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Amiens, 프랑스, 80054
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Marseille, 프랑스, 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
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Paris, 프랑스, 75014
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Saint Affrique, 프랑스, 12400
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Saint-Etienne, 프랑스, 42055
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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
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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
다른 이름들:
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위약 비교기: Placebo
every day (QD), by mouth (PO), 13 weeks
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every day (QD), by mouth (PO), 13 weeks
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores
기간: Baseline, Week 13
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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).
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Baseline, Week 13
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Patient's Global Impression of Improvement (PGI-I)
기간: Week 13
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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).
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Week 13
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Change From Baseline to Week 13 and Week 54 Endpoints in Roland Morris Disability Questionnaire-24 Item (RMDQ-24) Total Score
기간: Baseline, Week 13, Week 54
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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).
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Baseline, Week 13, Week 54
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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
기간: Baseline, Week 13
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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.
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Baseline, Week 13
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Change From Baseline to Week 13 and Week 54 Endpoints in Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I) Scores
기간: Baseline, Week 13, Week 54
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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.
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Baseline, Week 13, Week 54
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Change From Baseline to Week 13 and Week 54 Endpoints in Clinical Global Impression of Severity (CGI-Severity)
기간: Baseline, Week 13, Week 54
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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).
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Baseline, Week 13, Week 54
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Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 30% Score Reduction Criteria
기간: Week 13
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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.
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Week 13
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Number of Participants Who Responded to Treatment at Week 13 Endpoint Based on 50% Score Reduction Criteria
기간: Week 13
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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.
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Week 13
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Change From Baseline to Week 13 and Week 54 Endpoints in Athens Insomnia Scale
기간: Baseline, Week 13, Week 54
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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.
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Baseline, Week 13, Week 54
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Change From Baseline to Week 13 Endpoint in 36-Item Short-Form Health Survey (SF-36)
기간: Baseline, Week 13
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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.
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Baseline, Week 13
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Change From Baseline to Week 13 Endpoint in EuroQoL Questionnaire - 5 Dimension (EQ-5D)
기간: Baseline, Week 13
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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.
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Baseline, Week 13
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Change From Baseline to Week 13 and Week 54 Endpoints in Work Productivity and Activity Impairment Instrument (WPAI) Scores
기간: Baseline, Week 13, Week 54
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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.
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Baseline, Week 13, Week 54
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Change From Baseline to Week 13 and Week 54 Endpoints in Beck Depression Inventory (BDI-II) Total Scores
기간: Baseline, Week 13, Week 54
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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.
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Baseline, Week 13, Week 54
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Change From Baseline to Week 13 Endpoint in Hospital Anxiety and Depression Scale (HADS) Scores
기간: Baseline, Week 13
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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.'
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Baseline, Week 13
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Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Bicarbonate
기간: Baseline, Week 13
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Baseline, Week 13
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Laboratory Assessments That Were Statistically Significantly Different Between Treatment Groups in Change From Baseline to Week 13 Endpoint: Uric Acid
기간: Baseline, Week 13
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Baseline, Week 13
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Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate
기간: Baseline, Week 13, Week 54
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Baseline, Week 13, Week 54
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Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Blood Pressure
기간: Baseline, Week 13, Week 54
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Baseline, Week 13, Week 54
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Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight
기간: Baseline, Week 13, Week 54
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Baseline, Week 13, Week 54
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serious Adverse Events During the Dose-Blind Extension Phase
기간: Week 13 though Week 54
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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.
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Week 13 though Week 54
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Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Patients During the Dose-Blind Extension Phase
기간: Week 13 through Week 54
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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.
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Week 13 through Week 54
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Williamson OD, Schroer M, Ruff DD, Ahl J, Margherita A, Sagman D, Wohlreich MM. Onset of response with duloxetine treatment in patients with osteoarthritis knee pain and chronic low back pain: a post hoc analysis of placebo-controlled trials. Clin Ther. 2014 Apr 1;36(4):544-51. doi: 10.1016/j.clinthera.2014.02.009. Epub 2014 Mar 17.
- Skljarevski V, Zhang S, Chappell AS, Walker DJ, Murray I, Backonja M. Maintenance of effect of duloxetine in patients with chronic low back pain: a 41-week uncontrolled, dose-blinded study. Pain Med. 2010 May;11(5):648-57. doi: 10.1111/j.1526-4637.2010.00836.x. Epub 2010 Apr 13.
- Skljarevski V, Desaiah D, Liu-Seifert H, Zhang Q, Chappell AS, Detke MJ, Iyengar S, Atkinson JH, Backonja M. Efficacy and safety of duloxetine in patients with chronic low back pain. Spine (Phila Pa 1976). 2010 Jun 1;35(13):E578-85. doi: 10.1097/BRS.0b013e3181d3cef6.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2007년 1월 1일
기본 완료 (실제)
2007년 12월 1일
연구 완료 (실제)
2008년 10월 1일
연구 등록 날짜
최초 제출
2007년 1월 17일
QC 기준을 충족하는 최초 제출
2007년 1월 17일
처음 게시됨 (추정)
2007년 1월 19일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2009년 11월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2009년 11월 18일
마지막으로 확인됨
2009년 11월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 10544 (기타 식별자: Fred Hutch/University of Washington Cancer Consortium)
- F1J-MC-HMEN
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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