A Study Comparing Duloxetine and Placebo in the Treatment of Fibromyalgia
2010年5月28日 更新者：Eli Lilly and Company
Flexible Dosed Duloxetine Versus Placebo in the Treatment of Fibromyalgia
The purpose of this study is to confirm the efficacy and safety of duloxetine 60-120 mg once daily in comparison to placebo on symptom improvement in patients meeting criteria for fibromyalgia aged 18 and older.
Patients will be randomized to duloxetine or placebo, however, all patients will receive duloxetine at some point in the study.
調査の概要
研究の種類
介入
入学 (実際)
530
段階
- フェーズ 4
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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Phoenix、Arizona、アメリカ、85050
- 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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Tucson、Arizona、アメリカ、85741
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California
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Los Angeles、California、アメリカ、90024
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Pasadena、California、アメリカ、91105
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Connecticut
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Cromwell、Connecticut、アメリカ、06416
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Danbury、Connecticut、アメリカ、06810
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Florida
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Bradenton、Florida、アメリカ、34208
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Deland、Florida、アメリカ、32720
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Fort Myers、Florida、アメリカ、33912
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Orlando、Florida、アメリカ、32806
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South Miami、Florida、アメリカ、33143
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Tampa、Florida、アメリカ、33606
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West Palm Beach、Florida、アメリカ、33407
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Illinois
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Oak Brook、Illinois、アメリカ、60523
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Indiana
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Lafayette、Indiana、アメリカ、47905
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Kansas
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Prairie Village、Kansas、アメリカ、66206
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Maryland
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Rockville、Maryland、アメリカ、20852
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Massachusetts
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Belmont、Massachusetts、アメリカ、02478
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Fall River、Massachusetts、アメリカ、02721
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Newton、Massachusetts、アメリカ、02462
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Springfield、Massachusetts、アメリカ、01103
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Michigan
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Ann Arbor、Michigan、アメリカ、48104
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Missouri
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St Louis、Missouri、アメリカ、63141
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New Jersey
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Edison、New Jersey、アメリカ、08817
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Piscataway、New Jersey、アメリカ、08854
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North Carolina
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Greensboro、North Carolina、アメリカ、27408
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Ohio
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Cincinnati、Ohio、アメリカ、45219
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Toledo、Ohio、アメリカ、43623
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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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Eugene、Oregon、アメリカ、97404
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Portland、Oregon、アメリカ、97210
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19107
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South Carolina
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Myrtle Beach、South Carolina、アメリカ、29572
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Texas
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Dallas、Texas、アメリカ、75231
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Lake Jackson、Texas、アメリカ、77566
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San Antonio、Texas、アメリカ、78229
- 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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Waco、Texas、アメリカ、76708
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Wichita Falls、Texas、アメリカ、76309
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Utah
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West Jordan、Utah、アメリカ、84088
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Washington
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Bellevue、Washington、アメリカ、98007
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Seattle、Washington、アメリカ、98104
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Tacoma、Washington、アメリカ、98405
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Wisconsin
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Middleton、Wisconsin、アメリカ、53562
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Hato Rey、プエルトリコ、00918
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Ponce、プエルトリコ、00716
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San Juan、プエルトリコ、00935
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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 patients
- aged 18 and older who meet criteria for fibromyalgia as defined by the American College of Rheumatology
- have a score of at least 4 on the average pain item of the Brief Pain Inventory (BPI) (modified short form) at visits 1 and 2
- all females must test negative for pregnancy at the time of enrollment
- have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator.
Exclusion Criteria:
- have pain symptoms related to traumatic injury, structural rheumatic disease, or regional rheumatic disease that will interfere with interpretation of outcome measures
- have regional pain syndrome, multiple surgeries or failed back syndrome
- have confirmed current or previous diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (i.e. systemic lupus erythematosus)
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
60-120 mg, oral, every day, 12 weeks
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60-120 mg, oral, every day, 12 weeks (acute blinded phase followed by a 12 week blinded continuation phase).
他の名前：
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プラセボコンパレーター：Placebo
oral, daily, 12 weeks
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oral, daily, 12 weeks (acute blinded phase followed by 12 weeks of blinded duloxetine treatment)
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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 |
|---|---|---|
|
Patient's Global Impressions of Improvement (PGI-I) at Week 12
時間枠：12 weeks
|
The PGI-Improvement scale is a patient-rated instrument that measures perceived improvement in symptoms.
It is a 7-point scale where a score of 1 indicates that the patient is "very much improved," a score of 4 indicates that the patient has experienced "no change," and a score of 7 indicates that the patient is "very much worse."
|
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 in Brief Pain Inventory (BPI) (Modified Short Form) at 12 Week Endpoint
時間枠：Baseline, 12 weeks
|
BPI is a self-reported form that assesses severity of pain and the interference of pain on function.
There are 4 questions assessing the severity for worst pain, least pain, and average pain in the past 24 hours, and the pain right now.
Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).
There are 7 questions assessing the interference of pain in the past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life.
Interference scores range from 0 (does not interfere) to 10 (completely interferes).
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Baseline, 12 weeks
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Change From Baseline in Multidimensional Fatigue Inventory (MFI) at 12 Week Endpoint
時間枠：Baseline, 12 weeks
|
MFI is a 20-item, self-reporting instrument designed to collect data on the following 5 dimensions: general fatigue, physical fatigue, mental fatigue, reduced motivation, and reduced activity.
Each dimension score is derived by summing the scores of the 4 individual items that pertain to each dimension.
Item scores range from 1 to 5; thus, dimensional scores range from 4 to 20 with a higher score reflecting greater levels of fatigue.
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Baseline, 12 weeks
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Change From Baseline in Beck Depression Inventory-II (BDI-II) at 12 Week Endpoint
時間枠：Baseline, 12 weeks
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BDI-II is a 21-item patient-completed questionnaire designed to assess characteristics of depression.
Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme).
This questionnaire will be used to rate the severity of depressive symptoms and any improvement during the course of the trial.
The total score ranges from 0 to 63; the higher the score, the more severe the depressive symptoms.
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Baseline, 12 weeks
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Change From Baseline in Clinical Global Impressions of Severity (CGI-S) at 12 Week Endpoint
時間枠：Baseline, 12 Weeks
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The Clinical Global Impressions of Severity (CGI-Severity) scale evaluates the severity of illness at the time of assessment.
The score ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
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Baseline, 12 Weeks
|
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Change From Baseline in Beck Anxiety Inventory (BAI) at 12 Week Endpoint
時間枠：Baseline, 12 weeks
|
BAI is a 21-item patient-completed questionnaire designed to assess characteristics of anxiety.
Each item is rated on a 4-point scale (0 = not present; 3 = present in the extreme).
This questionnaire will be used to rate the severity of anxiety symptoms and any improvement during the course of the trial.
The total score ranges from 0 to 63; the higher the score, the more severe the anxiety symptoms.
|
Baseline, 12 weeks
|
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Change From Baseline in 36-Item Short-form Health Survey (SF-36) at 12 Weeks
時間枠：Baseline, 12 weeks
|
The patient-rated SF-36 consists of 36 questions covering eight health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function, and vitality.
Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning.
Two summary scores: the Physical Component Summary and the Mental Component Summary are constructed based on the eight SF-36 domains.
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Baseline, 12 weeks
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Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total Score at 12 Week Endpoint
時間枠：Baseline, 12 weeks
|
The MGH-CPFQ is a self-report instrument consisting of seven questions pertaining to an individual's cognitive and physical well-being.
Each question is rated 1 = "greater than normal" to 6 = "totally absent".
Total score ranges from 7 to 42.
|
Baseline, 12 weeks
|
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Change From Baseline in the Mood, Anxiety, Pain, Sleep, and Stiffness Likert Scale at 12 Week Endpoint
時間枠：Baseline, 12 weeks
|
Likert scales are patient-rated assessments.
Mood: feeling low, sad or depressed; rated 0 = not feeling low, sad or depressed to 10 = feeling extremely low, sad or depressed.
Anxious: anxious feelings; rated 0 = not feeling anxious to 10 = extremely anxious.
Sleep: how much patient bothered by sleep difficulties; rated 0 = not bothered to 10 = extremely bothered.
Pain: how much patient bothered by painful physical discomforts; rated 0 = not bothered to 10 = extremely bothered.
Stiffness: how stiff patient felt in past 24 hours; rated 0 = not felt any stiffness to 10 = felt extremely stiff.
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Baseline, 12 weeks
|
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Number of Responders: 30% Improvement in Brief Pain Inventory Average Pain at 12 Week Endpoint
時間枠：12 Weeks
|
Response was defined as at least 30% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score.
BPI average pain score assesses the severity of the average pain in the past 24 hours.
The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
|
12 Weeks
|
|
Number of Responders: 50% Improvement in Brief Pain Inventory Average Pain Score at 12 Week Endpoint
時間枠：12 weeks
|
Response was defined as at least 50% reduction from baseline to endpoint (last observation carried forward) for BPI average pain score.
BPI average pain score assesses the severity of the average pain in the past 24 hours.
The average severity score ranges from 0 (no pain) to 10 (pain as bad as you can imagine).
|
12 weeks
|
|
Change From Baseline in Blood Pressure at 12 Week Endpoint
時間枠：Baseline, 12 weeks
|
Baseline, 12 weeks
|
|
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Change From Baseline in Heart Rate at 12 Week Endpoint
時間枠：Baseline, 12 weeks
|
Baseline, 12 weeks
|
|
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Number of Patients With Columbia Suicide Severity Rating Scale (CSSR-S) Events (Behaviors, Ideations, Acts)
時間枠：Baseline through 12 Weeks
|
C-SSRS: scale capturing occurrence, severity, and frequency of suicide-related thoughts and behaviors.
Number of patients with suicidal behaviors, ideations, and acts are provided.
Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide.
Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.
Suicidal act: a "yes" answer to actual attempt or completed suicide.
|
Baseline through 12 Weeks
|
|
Change From Baseline in Weight at 12 Week Endpoint
時間枠：Baseline, 12 weeks
|
Baseline, 12 weeks
|
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
- Mohs R, Mease P, Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. The effect of duloxetine treatment on cognition in patients with fibromyalgia. Psychosom Med. 2012 Jul-Aug;74(6):628-34. doi: 10.1097/PSY.0b013e31825b9855. Epub 2012 Jun 28.
- Arnold LM, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Improvement in multiple dimensions of fatigue in patients with fibromyalgia treated with duloxetine: secondary analysis of a randomized, placebo-controlled trial. Arthritis Res Ther. 2011 Jun 13;13(3):R86. doi: 10.1186/ar3359.
- Arnold LM, Clauw D, Wang F, Ahl J, Gaynor PJ, Wohlreich MM. Flexible dosed duloxetine in the treatment of fibromyalgia: a randomized, double-blind, placebo-controlled trial. J Rheumatol. 2010 Dec;37(12):2578-86. doi: 10.3899/jrheum.100365. Epub 2010 Sep 15.
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6月1日
一次修了 (実際)
2009年4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5月5日
QC基準を満たした最初の提出物
2008年5月6日
最初の投稿 (見積もり)
2008年5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6月24日
QC基準を満たした最後の更新が送信されました
2010年5月28日
最終確認日
2010年5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
- 12220 (その他の識別子：Company Internal)
- F1J-US-HMGB (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。