A Study in Depression and Associated Painful Physical Symptoms
2012年1月10日 更新者：Eli Lilly and Company
Duloxetine Versus Placebo in the Acute Treatment of Patients With Major Depressive Disorder and Associated Painful Physical Symptoms
The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.
調査の概要
研究の種類
介入
入学 (実際)
527
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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California
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Sherman Oaks、California、アメリカ、91403
- 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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Connecticut
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Cromwell、Connecticut、アメリカ、06416
- 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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Florida
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Fort Lauderdale、Florida、アメリカ、33319
- 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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Orlando、Florida、アメリカ、32806
- 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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Georgia
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Atlanta、Georgia、アメリカ、30308
- 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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Illinois
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Hoffman Estates、Illinois、アメリカ、60194
- 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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Springfield、Illinois、アメリカ、62711
- 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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Indiana
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Evansville、Indiana、アメリカ、47714
- 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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Kentucky
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Florence、Kentucky、アメリカ、41042
- 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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Louisiana
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Lake Charles、Louisiana、アメリカ、70601
- 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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Massachusetts
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Belmont、Massachusetts、アメリカ、02478
- 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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Boston、Massachusetts、アメリカ、02135
- 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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Michigan
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Troy、Michigan、アメリカ、48083
- 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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New Jersey
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Toms River、New Jersey、アメリカ、08755
- 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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Willingboro、New Jersey、アメリカ、08046
- 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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New York
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Brooklyn、New York、アメリカ、11235
- 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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Rochester、New York、アメリカ、14618
- 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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Staten Island、New York、アメリカ、10305
- 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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Ohio
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Beachwood、Ohio、アメリカ、44122
- 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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Toledo、Ohio、アメリカ、43623
- 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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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73109
- 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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Oregon
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Portland、Oregon、アメリカ、97210
- 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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Salem、Oregon、アメリカ、97301
- 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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Pennsylvania
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Allentown、Pennsylvania、アメリカ、18104
- 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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Media、Pennsylvania、アメリカ、19063
- 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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Philadelphia、Pennsylvania、アメリカ、19107
- 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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Rhode Island
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Lincoln、Rhode Island、アメリカ、02865
- 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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Tennessee
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Memphis、Tennessee、アメリカ、38119
- 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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Texas
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Wichita Falls、Texas、アメリカ、76309
- 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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Virginia
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Richmond、Virginia、アメリカ、23230
- 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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Washington
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Bellevue、Washington、アメリカ、98007
- 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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Wisconsin
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Middleton、Wisconsin、アメリカ、53562
- 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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Caguas、プエルトリコ、00725
- 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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San Juan、プエルトリコ、00926
- 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
Key Inclusion Criteria:
- Meets criteria for Major Depressive Disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by the Mini International Neuropsychiatric Interview (MINI)
- Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than or equal to 20 during the Screening Phase
- At least 1 previous episode of depression
- Painful physical symptoms with a score greater than or equal to 3 on the Brief Pain Inventory-Short Form (BPI-SF) average pain question
- A Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4 during the Screening Phase
- Written informed consent
Key Exclusion Criteria:
- Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
- Have previously completed or withdrawn from this study or any other study investigating duloxetine (unless no study drug was received)
- Women of child-bearing potential who are not using a medically accepted means of contraception
- Have any current (within past 6 months) DSM-IV-TR primary Axis I diagnosis other than MDD
- Have a history of alcohol abuse and/or substance abuse or dependence within 1 year prior to being screened for the study
- Have any prior history of bipolar disorder, psychosis, or schizophrenia
- Have an Axis II disorder that would interfere with study compliance
- Lack of response of any episode of major depression (lifetime of subject) to two or more adequate courses of antidepressant therapy, at a clinically appropriate dose for at least 4 weeks or, alternatively, in the judgment of the investigator, the subject meets criteria for treatment resistant depression
- Have previously received treatment of MDD or Generalized Anxiety Disorder (GAD) with an adequate trial of duloxetine and did not respond or could not tolerate duloxetine
- Diagnosis of acute liver injury or severe cirrhosis
- Uncontrolled narrow-angle glaucoma
- Positive urine drug screen for any substance of abuse
- Have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require intervention, hospitalization, or use of an excluded medication during the study
- History of a serious suicide attempt or subject judged clinically to be at serious suicidal risk
- Requires continuous use of analgesics for 6 or more months because of chronic pain
- Has pain of a known origin
- Meets criteria for fibromyalgia as defined by the American College of Rheumatology
- Experiences greater than or equal to 1 migraine headache per week
- Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within 1 year prior to being screened for the study
- Initiating, changing, or stopping psychotherapy within 6 weeks prior to being screened for the study or at any time during the study
- Investigator or subject anticipates initiating, changing, or stopping non-pharmacologic or alternative therapies for painful physical symptoms at any time during the study
- Are taking any excluded medications within 7 days prior to randomization with the exception of fluoxetine which cannot be taken within 30 days prior to randomization
- Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to randomization or have the potential need to use an MAOI during the study or within 5 days after discontinuation of study drug
- Abnormal thyroid stimulating hormone
- Has epilepsy or history of seizure disorder or received treatment with anticonvulsant medication for epilepsy or seizures
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：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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プラセボコンパレーター：プラセボ
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Participants received placebo QD, po for 8 weeks, followed by placebo QD, po during the 2-week taper phase.
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実験的：デュロキセチン
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Participants received 30 milligrams (mg) duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD po for 7 weeks.
Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
他の名前：
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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 in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-Week Treatment Period
時間枠：Day 1 through 8 weeks
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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).
The overall change is based on the estimated main treatment effect.
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
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Day 1 through 8 weeks
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Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 8
時間枠：Baseline, 8 weeks
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The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
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Baseline, 8 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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8週目のシーハン障害スケール（SDS）の合計スコアと項目スコアのベースラインからの変化
時間枠：ベースライン、8週間
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SDS は参加者によって完成されます。参加者の症状が仕事/社会/家庭生活に及ぼす影響を評価するために使用されます。
合計スコアの範囲は 0 ～ 30 です。値が高いほど、参加者の仕事/社会/家庭生活に大きな混乱が生じていることを示します。
各項目のスコアは 0 から 10 の範囲であり、値が高いほど、参加者の仕事/学校生活 (項目 1)、社会生活/余暇活動 (項目 2)、または家族生活/家庭での責任 (項目 3) に大きな混乱が生じていることを示します。
LS 平均値は、治療、治験責任医師、来院、ベースライン、治療と来院の相互作用、およびベースラインと来院の相互作用に対して調整されました。
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ベースライン、8週間
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8週目の簡易疼痛インベントリの重症度および干渉スコア（BPI-S/BPI-I）のベースラインからの変化
時間枠：ベースライン、8週間
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痛みの重症度と機能への影響を測定します。
重症度スコア: 各質問について 0 (痛みなし) ～ 10 (重度の痛み)。
干渉スコア: 一般的な活動、気分、歩行能力、通常の仕事、他人との関係、睡眠、人生の楽しみについて、過去 24 時間の痛みの干渉を各質問で 0 (干渉しない) から 10 (完全に干渉する) で評価します。
平均干渉 = 個々の干渉項目の非欠損スコアの平均。
治療、治験責任医師、来院、ベースライン、治療と来院の相互作用、およびベースラインと来院の相互作用について調整された LS 平均値。
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ベースライン、8週間
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Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8
時間枠：Baseline, up to 8 weeks
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The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Remission is defined as achieving a MADRS total score ≤12.
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Baseline, up to 8 weeks
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Percentage of Participants Achieving Remission up to Week 8
時間枠：Up to 8 weeks
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The Montgomery-Asberg Depression Rating Scale (MADRS) is a rating scale for severity of depressive mood symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Remission is defined as achieving a MADRS total score ≤12 at the last 2 nonmissing visits (for example, visit 3 [week 1] and visit 4 [week 2], or visit 4 [week 2] and visit 5 [week 4], or visit 5 [week 4] and visit 6 [week 8]).
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Up to 8 weeks
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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 4
時間枠：Baseline, 4 weeks
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The MADRS is a rating scale for severity of depressive mood and symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale from 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
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Baseline, 4 weeks
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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Week 2
時間枠：Baseline, 2 weeks
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The MADRS is a rating scale for severity of depressive mood symptoms.
The MADRS has a 10-item checklist.
Items are rated on a scale of 0-6, for a total score range from 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, baseline, treatment*visit interaction, and baseline*visit interaction.
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Baseline, 2 weeks
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Patient Global Impression of Improvement (PGI-I) Score at Week 8
時間枠：8 weeks
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A scale that measures the participant'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).
The Least Squares (LS) Mean Value was adjusted for treatment, investigator, visit, and treatment*visit interaction.
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8 weeks
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Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-Blind Treatment Phase
時間枠：Baseline through 8 weeks
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The C-SSRS captures occurrence, severity, and frequency of suicide-related thoughts and behaviors.
Number of participants 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, and completed suicide.
Suicidal ideation: a "yes" answer to any 1 of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation.
Suicidal acts: a "yes" answer to actual attempt or completed suicide.
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Baseline through 8 weeks
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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8週目までの脈拍数のベースラインからの変化
時間枠：ベースライン、8週目まで
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8週目の脈拍数のベースラインからの変化が主な分析です。 脈拍数の一次分析では、治療、研究者、ベースライン、治療と来院の相互作用、およびベースラインと来院の相互作用に対して最小二乗法 (LS) 平均値を調整しました。 ベースラインから 8 週目までの脈拍数の変化が二次分析です。 LS 平均値は、治療、研究者、およびベースラインに合わせて調整されました。 |
ベースライン、8週目まで
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8週目までの最高血圧（SBP）および最低血圧（DBP）のベースラインからの変化
時間枠：ベースライン、8週目まで
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8週目のSBPおよびDBPのベースラインからの変化が一次分析です。 SBPおよびDBPの一次分析では、最小二乗法（LS）平均値が治療、治験責任医師、ベースライン、治療*来院相互作用、およびベースライン*来院相互作用に対して調整されました。 8週目までのSBPおよびDBPのベースラインからの変化が二次分析です。 LS 平均値は、治療、研究者、およびベースラインに合わせて調整されました。 |
ベースライン、8週目まで
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8週目までのベースラインからの体重変化
時間枠：ベースライン、8週目まで
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8週目の体重のベースラインからの変化が主な分析です。 体重の一次分析では、治療、治験責任医師、ベースライン、治療と来院の相互作用、およびベースラインと来院の相互作用に対して最小二乗法 (LS) 平均値を調整しました。 ベースラインから 8 週目までの体重の変化が二次分析です。 LS 平均値は、治療、研究者、およびベースラインに合わせて調整されました。 |
ベースライン、8週目まで
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Number of Participants With Abnormal Laboratory Values During the Double-Blind Treatment Phase - High Creatinine
時間枠：Baseline through 8 weeks
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Laboratory assessment of creatinine during the double-blind treatment phase.
Normal creatinine ranges for males are 40.00
micromoles per liter (µmol/L) (low) to 110.00 µmol/L (high).
Normal creatinine ranges for females are 31.00
µmol/L (low) to 101.00 µmol/L (high).
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Baseline through 8 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
- Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Stat Med. 2003 Aug 15;22(15):2387-400. doi: 10.1002/sim.1526.
- Gaynor PJ, Gopal M, Zheng W, Martinez JM, Robinson MJ, Hann D, Marangell LB. Duloxetine versus placebo in the treatment of major depressive disorder and associated painful physical symptoms: a replication study. Curr Med Res Opin. 2011 Oct;27(10):1859-67. doi: 10.1185/03007995.2011.609540. Epub 2011 Aug 12.
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
2010年3月1日
一次修了 (実際)
2011年3月1日
研究の完了 (実際)
2011年3月1日
試験登録日
最初に提出
2010年2月16日
QC基準を満たした最初の提出物
2010年2月16日
最初の投稿 (見積もり)
2010年2月18日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年2月13日
QC基準を満たした最後の更新が送信されました
2012年1月10日
最終確認日
2012年1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
- 13630
- F1J-US-HMGU (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。