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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.

調査の概要

状態

完了

条件

介入・治療

研究の種類

介入

入学 (実際)

236

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

  • オランダ
      • Amsterdam、オランダ、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、オランダ、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
  • ドイツ
      • Ellwangen、ドイツ、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、ドイツ、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、ドイツ、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、ドイツ、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
  • フランス
      • Amiens、フランス、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、フランス、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、フランス、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、フランス、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、フランス、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
  • ブラジル
      • Curitiba、ブラジル、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、ブラジル、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、ブラジル、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
  • メキシコ
      • Mexico City、メキシコ、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、メキシコ、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、メキシコ、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

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/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

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：単一グループの割り当て
  • 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
実験的：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
薬：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
他の名前：
  • サインバルタ
  • LY248686
プラセボコンパレーター：Placebo
every day (QD), by mouth (PO), 13 weeks
薬：Placebo
every day (QD), by mouth (PO), 13 weeks

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
Change From Baseline to Week 13 in Brief Pain Inventory (BPI), 24-hour Average Pain Scores
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Patient's Global Impression of Improvement (PGI-I)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline, Week 13
Baseline, Week 13
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Pulse Rate
時間枠：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
時間枠：Baseline, Week 13, Week 54
Baseline, Week 13, Week 54
Change From Baseline to Week 13 and Week 54 Endpoints in Vital Signs: Weight
時間枠：Baseline, Week 13, Week 54
Baseline, Week 13, Week 54

その他の成果指標

結果測定
メジャーの説明
時間枠
Serious Adverse Events During the Dose-Blind Extension Phase
時間枠：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
時間枠：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

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

Eli Lilly and Company

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

便利なリンク

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

2007年1月1日

一次修了 (実際)

2007年12月1日

研究の完了 (実際)

2008年10月1日

試験登録日

最初に提出

2007年1月17日

QC基準を満たした最初の提出物

2007年1月17日

最初の投稿 (見積もり)

2007年1月19日

学習記録の更新

投稿された最後の更新 (見積もり)

2009年11月20日

QC基準を満たした最後の更新が送信されました

2009年11月18日

最終確認日

2009年11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

  • 10544 (その他の識別子：Fred Hutch/University of Washington Cancer Consortium)
  • F1J-MC-HMEN

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。

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