此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

A Study of Duloxetine in Adolescents With Juvenile Primary Fibromyalgia Syndrome

2019年9月5日 更新者：Eli Lilly and Company

Effect of Duloxetine 30/60 mg Once Daily Versus Placebo in Adolescents With Juvenile Primary Fibromyalgia Syndrome

The purpose of this study is to determine whether duloxetine is safe and effective in the treatment of adolescents with Juvenile Primary Fibromyalgia Syndrome (JPFS).

This trial consists of two distinct study periods. A blinded treatment period of 13 weeks and an open label extension period of 26 weeks.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

184

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 印度
      • Chennai、印度、600003
        • 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.
      • Hyderabad、印度、500034
        • 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.
      • Mysore、印度、570004
        • 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.
      • Raipur、印度、492001
        • 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.
  • 波多黎各
      • San Juan、波多黎各、00912
        • Centro de Investigaciones Clinicas
      • San Juan、波多黎各、00926
        • Centro Pediatrico Paseos
  • 美国
    • Arizona
      • Phoenix、Arizona、美国、85032
        • NoesisPharma
    • California
      • Loma Linda、California、美国、92354
        • Loma Linda University School of Medicine
      • National City、California、美国、91950
        • Synergy Clinical Research
    • Connecticut
      • Cromwell、Connecticut、美国、06416
        • Connecticut Clinical Trials LLC
      • Fairfield、Connecticut、美国、06824
        • Associated Neurologists of Southern Connecticut
    • Florida
      • West Palm Beach、Florida、美国、33409
        • Palm Beach Research Center
    • Georgia
      • Smyrna、Georgia、美国、30080
        • Institute For Behavioral Medicine
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Riley Hosptial for Children
    • Kentucky
      • Lexington、Kentucky、美国、40504
        • Kentucky Medical Research Center
    • Missouri
      • Saint Louis、Missouri、美国、63141
        • Mercy Health Research
    • New Hampshire
      • Nashua、New Hampshire、美国、03060
        • Healthy Perspectives Innovative Mental Health Services, PL
    • New Mexico
      • Albuquerque、New Mexico、美国、87109
        • Albuquerque Neurosciences
    • New York
      • Mount Kisco、New York、美国、10549
        • Bioscience Research, LLC
      • Staten Island、New York、美国、10312
        • Richmond Behavorial Associates
    • Ohio
      • Canton、Ohio、美国、44718
        • Neurobehavioral Clinical Research
      • Cincinnati、Ohio、美国、45219
        • Univ of Cincinnati College of Medicine
      • Middleburg Heights、Ohio、美国、44130
        • North Star Research
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73109
        • Neuropsychiatric Center
    • Pennsylvania
      • Duncansville、Pennsylvania、美国、16635
        • Altoona Center for Clinical Research
      • Philadelphia、Pennsylvania、美国、19139
        • CRI Lifetree
    • Tennessee
      • Kingsport、Tennessee、美国、37660
        • Holston Medical Group Clinical Research
    • Texas
      • San Antonio、Texas、美国、78232
        • Arthritis and Osteoporosis Center of South Texas
    • Utah
      • Salt Lake City、Utah、美国、84102
        • Bateman Horne Center of Excellence
    • Virginia
      • Herndon、Virginia、美国、20170-2613
        • Neuroscience, Inc.
      • Virginia Beach、Virginia、美国、23505
        • Advanced Pain Management
    • Washington
      • Bellevue、Washington、美国、98007-4209
        • Northwest Clinical Research Center
  • 阿根廷
      • San Miguel De Tucuman、阿根廷、T4000AXL
        • 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.

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

13年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria

  • Meet criteria for primary JPFS
  • Have a score of greater than or equal to 4 on Brief Pain Inventory (BPI) average pain severity (Item 3) during screening
  • Female participants must have a negative serum pregnancy test during screening
  • Participant's parent/legal representative and participant judged to be reliable to keep all appointments for clinical tests and procedures
  • Participant's parent/legal representative and participant must have a degree of understanding such that they can communicate intelligently
  • Participants must be capable of swallowing investigational product whole
  • Participants must have venous access sufficient to allow blood sampling and be compliant with blood draws

Exclusion Criteria:

  • Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device or concurrently enrolled in any other type of medical research
  • Previously completed or withdrawn after randomization from a study investigating duloxetine
  • Known hypersensitivity to duloxetine or any of the inactive ingredients, or have frequent or severe allergic reactions to multiple medications
  • Treated with duloxetine within the last 6 months. Will not likely benefit from duloxetine treatment, in the opinion of the investigator or have had prior nonresponse or inadequate tolerance to duloxetine
  • Pain symptoms related to traumatic injury, past surgery, structural bone or joint disease or regional pain syndrome that will interfere with interpretation of outcome measures
  • Currently have evidence of rheumatologic disorder or have a current diagnosis of rheumatoid arthritis, inflammatory arthritis, or infectious arthritis, or an autoimmune disease (for example, systemic lupus erythematosus)
  • Have a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Axis I condition, currently or within the past year, except major depressive disorder (MDD) and/or generalized anxiety disorder (GAD), adjustment disorder or specific phobias with primary investigator approval
  • Have a current secondary DSM-IV Axis I condition of attention-deficit/hyperactivity disorder that requires pharmacologic treatment
  • Lifetime DSM-IV Axis I diagnosis of psychosis, bipolar disorder, or schizoaffective disorder
  • DSM-IV Axis II disorder which would interfere with protocol compliance
  • History of substance abuse or dependence within the 6 months
  • Positive urine drug screen for any substances of abuse or excluded medication
  • Family history of 1 or more first-degree relatives with diagnosed bipolar I disorder
  • Significant suicide attempt within 1 year of screening or are currently at suicidal risk in the opinion of the investigator
  • Weight less than 20 kilogram (kg) at screening
  • History of seizure disorder (other than febrile seizures)
  • Taking any excluded medications that cannot be discontinued at screening
  • Fluoxetine within 30 days prior to completion of screening
  • Monoamine oxidase inhibitor (MAOI) within 14 days of screening; or the potential need to use an MAOI during the study or within 5 days of discontinuation of investigational product
  • Abnormal thyroid-stimulating hormone (TSH) concentrations
  • Uncontrolled narrow-angle glaucoma
  • Acute liver injury (such as hepatitis) or severe cirrhosis (Child-Pugh Class C)
  • Serious or unstable medical illness
  • Female participants who are either pregnant, nursing or have recently given birth

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Duloxetine

Blinded treatment period: 30mg or 60mg once daily for 13 weeks

Open label extension: 30mg or 60mg Duloxetine once daily for 26 weeks

Taper period: 30mg Duloxetine or placebo once daily for 1 week.
药品：度洛西汀
口服给药
其他名称：
  • LY248686
安慰剂比较：Placebo

Blinded treatment period:Placebo once daily for 13 weeks

Open label extension: 30mg or 60mg Duloxetine once daily for 26 weeks

Taper period: 30mg Duloxetine or placebo once daily for 1 week.
药品：安慰剂
口服给药
药品：度洛西汀
口服给药
其他名称：
  • LY248686

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item
大体时间：Baseline, 13 weeks

Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.

Mixed Model Repeated Measure (MMRM) model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce Least Square (LS) means.
Baseline, 13 weeks

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline to 13 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-Adolescent Version Severity and Interference Items
大体时间：Baseline, 13 weeks

The Brief Pain Inventory (BPI) - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work.

MMRM model with terms for treatment, pooled investigator, visit, baseline, treatment by visit, and baseline by visit was used to produce LS means.
Baseline, 13 weeks
Maintenance Effect in Acute Phase Responders on the Brief Pain Inventory (BPI) Modified Short Form-adolescent Version 24 Hour Average Pain Severity Item
大体时间：Baseline (Extension Phase), 39 weeks

Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and the interference of pain on function.Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.

Acute phase responders: Participants with ≥30% pain reduction from baseline on the BPI average pain severity measure at the last non-missing assessment in acute phase.
Baseline (Extension Phase), 39 weeks
Number of Participants With Greater Than or Equal to 30% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks
大体时间：13 weeks

Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.

Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF).
13 weeks
Number of Participants With Greater Than or Equal to 50% Reduction From Baseline in BPI 24 Hour Average Pain Severity Score at 13 Weeks
大体时间：13 weeks

Brief Pain Inventory (BPI) modified short form is a self-reported scale that measures the severity of pain and interference of pain on function, Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine). Severity of pain is measured based on the average pain experienced over the past 24-hours.

Percent reduction of BPI 24 hour average pain from baseline to last observation carried forward (LOCF).
13 weeks
Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores
大体时间：Baseline, 13 weeks

Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for "pain now," worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain).

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score
大体时间：Baseline, 13 weeks

Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score
大体时间：Baseline, 13 weeks

Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill).

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline in Functional Disability Inventory Child Form (FDI-Child)
大体时间：Baseline, 13 weeks

Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline in Functional Disability Inventory Parent Form (FDI-Parent)
大体时间：Baseline, 13 weeks

Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline in Children's Depression Inventory (CDI)
大体时间：Baseline, 13 weeks

Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)
大体时间：Baseline, 13 weeks
Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for treatment, pooled investigator and baseline value.
Baseline, 13 weeks
Change From Baseline to 39 Week Endpoint in Brief Pain Inventory (BPI) Modified Short Form-adolescent Version Severity and Interference Items
大体时间：Baseline (extension phase), 39 weeks

The BPI - Modified Short Form Adolescent Version is a self-reported scale that measures the severity of pain and the interference of pain on function. The Severity scores range from 0 (no pain) to 10 (pain as bad as you can imagine).There are 4 questions assessing the severity for worst pain, least pain, average pain in the past 24 hours (which is the primary efficacy measure), and the pain right now. The Interference scores range from 0 (does not interfere) to 10 (completely interferes). There are 7 original questions assessing the interference of pain in the past 24 hours on the following: general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. The BPI: Adolescent Version added an eighth interference question to assess interference of pain on school work.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Pediatric Pain Questionnaire (PPQ) Item Scores
大体时间：Baseline (extension phase), 39 weeks

Pediatric Pain Questionnaire (PPQ) is a self-reported scale that measures the severity for "pain now," worst pain, and average pain in the past week with 100 mm VAS (Visual Analog Scale). The severity scores range from 0 (no hurting, no discomfort, no pain) to 100 (hurting a whole lot, very uncomfortable, severe pain).

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Clinical Global Impression (CGI) Severity: Overall Illness Score
大体时间：Baseline (extension phase), 39 weeks

Clinical Global Impression of Severity: Overall Illness (CGI-S: Overall Illness) scale evaluates the severity of the overall illness of JPFS, including all relevant, associated symptoms. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The scoring is based on observed and reported symptoms and behaviors over the past 7 days that are ongoing at the time of the Study Visit.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Clinical Global Impression (CGI) Severity: Mental Illness Score
大体时间：Baseline (extension phase), 39 weeks

Clinical Global Impression of Severity: Mental Illness (CGI-S: Mental Illness) scale evaluates the severity of any diagnosed, comorbid Axis I/II condition. The scoring ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants without a diagnosed Axis I/II condition should receive a score of 1 (normal, not at all ill).

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS mean with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Functional Disability Inventory Child Form (FDI-child)
大体时间：Baseline (extension phase), 39 weeks

Functional Disability Inventory-child form (FDI-child) is a self-reported scale to assess the physical trouble or difficulty the child has doing regular activities. This scale contains 15 items. Each item is scored on a 0- to-4-point scale (0 = no trouble, 1 = a little trouble, 2 = some trouble, 3 = a lot of trouble, 4 = impossible).The total score ranges from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Functional Disability Inventory Parent Form (FDI-parent)
大体时间：Baseline (extension phase), 39 weeks

Functional Disability Inventory-parent form (FDI-parent) contains the same items as FDI-child, but is reported by parent/legal representative. The total score range from 0 to 60. The higher the score, the more physical trouble or difficulty the child has doing regular activities.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Children's Depression Inventory (CDI)
大体时间：Baseline (extension phase), 39 weeks

Children's Depression Inventory (CDI) is modeled after the Beck Depression Inventory and is a 27-item self-reported, symptom-oriented scale designed for school-aged children and adolescents. Each item is scored on a 0-to-2-point scale (in increasing severity) and thus the total score ranges from 0 to 54. The higher the score, the more severe the depression.

Analysis of Covariance (ANCOVA) model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks
Change From Baseline in Multidimensional Anxiety Scale for Children (MASC)
大体时间：Baseline (extension phase), 39 weeks
Multidimensional Anxiety Scale for Children (MASC) is a self-reported scale developed to assess anxiety in children and adolescents. The MASC consists of 39 items that comprise 4 factors with each item scored on a 0-to-3-point scale (0-never true about me, 1-rarely true about me, 2- sometimes true about me, 3-often true about me). : 1) physical symptoms (tense/restless and somatic/autonomic)-12 items with score range 0 to 36; 2) social anxiety (humiliation/rejection and public performance fears)-9 items with score range of 0 to 27; 3) harm avoidance (perfectionism and anxious coping)-9 items with score range of 0 to 27; and 4) separation anxiety-9 items with score range of 0 to 27. Total score ranges from 0 to 117. The higher the total score, the more severe the anxiety.ANCOVA model with last observation carried forward (LOCF) was used to produce LS means with terms for pooled investigator and baseline value.
Baseline (extension phase), 39 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Eli Lilly and Company

调查人员

  • 研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年3月1日

初级完成 (实际的)

2017年5月31日

研究完成 (实际的)

2017年11月28日

研究注册日期

首次提交

2010年11月8日

首先提交符合 QC 标准的

2010年11月8日

首次发布 (估计)

2010年11月9日

研究记录更新

最后更新发布 (实际的)

2019年9月20日

上次提交的符合 QC 标准的更新

2019年9月5日

最后验证

2019年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 14099 (其他标识符：City of Hope Medical Center)
  • F1J-MC-HMGW (其他标识符：Eli Lilly and Company)
  • CTRI/2011/07/001866 (注册表标识符：Clinical Trials Registry India)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD 共享时间框架

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD 共享访问标准

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅