A Study for Patient With Chronic Low Back Pain
2010年9月30日 更新者：Eli Lilly and Company
Effect of Duloxetine 60 mg Once Daily Versus Placebo in Patients With Chronic Low Back Pain
The purpose of this study is to determine if duloxetine reduces the severity of chronic low back pain.
調査の概要
研究の種類
介入
入学 (実際)
401
段階
- フェーズ 3
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arizona
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Chandler、Arizona、アメリカ、85225
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Connecticut
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Cromwell、Connecticut、アメリカ、06416
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Florida
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Deland、Florida、アメリカ、32720
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Jacksonville、Florida、アメリカ、32216
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Massachusetts
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Brighton、Massachusetts、アメリカ、02135
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73109
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Oregon
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Portland、Oregon、アメリカ、97210
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Rotterdam、オランダ、3039 BD
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Barcelona、スペイン、08025
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Bilboa、スペイン、48013
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Getafe、スペイン、28905
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La Coruña、スペイン、15006
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Madrid、スペイン、28009
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Aalen、ドイツ、73430
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Alzenau、ドイツ、63755
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Berlin、ドイツ、10629
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Ellwangen、ドイツ、73479
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Hamburg、ドイツ、20255
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Wiesbaden、ドイツ、65189
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Sa Coma、ブラジル、04230000
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São Paulo、ブラジル、04026-000
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Krakow、ポーランド、30-349
- 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 personal physician.
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Lublin、ポーランド、20-093
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Poznan、ポーランド、61-289
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Szczecin、ポーランド、70-376
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Moscow、ロシア連邦、119992
- 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 personal physician.
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Male or female outpatients with chronic low back pain
Exclusion Criteria:
- Cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
- Acute liver injury (such as hepatitis) or severe cirrhosis.
- Previous exposure to duloxetine.
- Body Mass Index (BMI) over 40.
- Major depressive disorder.
- Daily use of narcotics.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：Duloxetine
Participants received duloxetine 60 milligram by mouth once daily for 12 weeks of double-blind treatment
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60 mg orally once daily for 12 weeks
他の名前：
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プラセボコンパレーター：Placebo
Patients received placebo by mouth once daily for 12 weeks of double-blind treatment
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Placebo once daily orally for 12 weeks
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Change From Baseline to 12 Weeks in Brief Pain Inventory 24-hour Average Pain Score
時間枠：baseline, 12 weeks
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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).
Least Squares Mean values were controlled for investigator and baseline severity.
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baseline, 12 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change From Baseline to 12 Weeks on the Brief Pain Inventory - Severity (BPI-S) and Interference (BPI-I)
時間枠：baseline, 12 weeks
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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 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, 12 weeks
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Change From Baseline to 12 Weeks in Weekly Mean of 24-hour Average Pain, Worst Pain, and Night Pain Rating
時間枠：baseline, 12 weeks
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24-hour average pain severity scores were recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain).
Patients completed the electronic diary at bedtime.
The 11-point Likert scale was also used for assessment of night pain and worst pain each day, and evaluated as weekly means.
Least Squares Mean values were controlled for investigator and baseline severity.
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baseline, 12 weeks
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Number of Responders: 30 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint
時間枠：12 weeks
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Response to treatment was defined as at least a 30% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score.
BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Response was assessed at endpoint.
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12 weeks
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Number of Responders: 50 Percent (%) or Greater Reduction of the Brief Pain Inventory (BPI) Average Pain Severity Rating at 12 Week Endpoint
時間枠：12 weeks
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Response to treatment was defined as at least a 50% reduction from baseline to endpoint (last observation carried forward) in the BPI average pain severity score.
BPI is a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Response was assessed at endpoint.
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12 weeks
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Number of Sustained Responders at 12 Week Endpoint
時間枠：12 weeks
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Sustained responders: participants with ≥30% reduction of BPI average pain rating from baseline to endpoint and baseline to earlier visit than last visit and who maintain a ≥20% reduction of BPI average pain rating from baseline at every visit between last visit and earlier visit.
BPI: a self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours.
The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).
Number of sustained responders was assessed at endpoint.
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12 weeks
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Number of Participants Reaching Each Threshold of of BPI Average Pain Score Reduction During the Study - Cumulative Distribution
時間枠：12 weeks
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The results presented are the cumulative number of participants reaching each threshold of BPI average pain reduction.
The thresholds are given as percent reductions in BPI average pain score from the baseline score.
BPI: 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).
Number of participants under each threshold was assessed at endpoint.
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12 weeks
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Change From Baseline to 12 Weeks Endpoint in Clinical Global Impressions of Severity (CGI-S)
時間枠：baseline, 12 weeks
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Measures severity of illness at the time of assessment compared with start of treatment.
Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Least Squares Mean values were controlled for investigator and baseline severity.
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baseline, 12 weeks
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Patient's Global Impression of Improvement (PGI-I) at 12 Weeks
時間枠：12 weeks
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A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment.
The score ranges from 1 (very much better) to 7 (very much worse).
Least Squares Mean values were controlled for investigator and baseline severity.
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12 weeks
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Change From Baseline to 12 Weeks in Roland Morris Disability Questionnaire
時間枠：baseline, 12 weeks
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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).
Least Squares Mean values were controlled for investigator and baseline severity.
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baseline, 12 weeks
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Change From Baseline to 12 Weeks in Profile of Mood States - Brief Form
時間枠：baseline, 12 weeks
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The 30-item BPOMS measures mood states and has 6 factors: tension-anxiety (Ten), depression-dejection (Dep), anxiety-hostility (Ang), fatigue (Fat), confusion (Con), and vigor (Vig).
Item scores: 0 (not at all) to 4 (extremely).
Each factor scores range from 0 to 20.
The Total score is sum of all factor scores minus the factor score for vigor (Total=Ten+Dep+Ang+Fat+Con-Vig) and ranges from 0 (least disturbed) to 80 (most disturbed).
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baseline, 12 weeks
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Change From Baseline to 12 Weeks in 36-item Short-Form (SF-36) Health Survey
時間枠：baseline, 12 weeks
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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]).
The score for each of the domain and component summary=0-100 (higher scores indicate better health status or functioning).
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baseline, 12 weeks
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Change From Baseline to 12 Weeks in European Quality of Life Questionnaire - 5 Dimension
時間枠：baseline, 12 weeks
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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 5 domains will be mapped to a single index through an algorithm.
The index ranges between 0 and 1; higher scores indicate a better health state perceived by the patient.
Participants were evaluated with the United Kingdom (UK) and the United States (US) population based index score.
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baseline, 12 weeks
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Change From Baseline to 12 Weeks in Work Productivity and Activity Impairment Instrument (WPAI)
時間枠：baseline, 12 weeks
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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.
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baseline, 12 weeks
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Participants Who Discontinued From Baseline to 12 Weeks
時間枠：baseline, 12 weeks
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Reasons for discontinuation are listed in the participant flow.
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baseline, 12 weeks
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Change From Baseline to 12 Weeks in Uric Acid
時間枠：baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Albumin
時間枠：baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Alkaline Phosphatase
時間枠：baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Alanine Aminotransferase
時間枠：baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Aspartate Aminotransferase
時間枠：baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Creatinine
時間枠：baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Total Protein
時間枠：baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Weeks in Blood Pressure
時間枠：baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Weight
時間枠：baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Change From Baseline to 12 Week Endpoint in Pulse Rate
時間枠：baseline, 12 weeks
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Least Squares Mean values were controlled for investigator.
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baseline, 12 weeks
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Number of Participants With Suicidal Ideation or Suicidal Behaviors According to the Columbia Suicide Severity Rating Scale
時間枠：baseline through 12 weeks
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The Columbia Suicide Severity Rating Scale (C-SSRS) captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period.
The scale includes suggested questions to solicit the type of information needed to determine if a suicide-related thought or behavior occurred.
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baseline through 12 weeks
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Skljarevski V, Zhang S, Desaiah D, Alaka KJ, Palacios S, Miazgowski T, Patrick K. Duloxetine versus placebo in patients with chronic low back pain: a 12-week, fixed-dose, randomized, double-blind trial. J Pain. 2010 Dec;11(12):1282-90. doi: 10.1016/j.jpain.2010.03.002. Epub 2010 May 15.
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2008年9月1日
一次修了 (実際)
2009年7月1日
研究の完了 (実際)
2009年7月1日
試験登録日
最初に提出
2008年10月3日
QC基準を満たした最初の提出物
2008年10月6日
最初の投稿 (見積もり)
2008年10月7日
学習記録の更新
投稿された最後の更新 (見積もり)
2010年10月18日
QC基準を満たした最後の更新が送信されました
2010年9月30日
最終確認日
2010年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 12360
- F1J-MC-HMGC (その他の識別子：Eli Lilly and Company)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。