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Migraine Study in Adolescent Patients

2016年11月30日 更新者：GlaxoSmithKline

TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents

This study was designed to determine how well the combination medication, sumatriptan and naproxen sodium, treats migraine headache in adolescents 12-17 years old

研究概览

地位

完全的

条件

干预/治疗

详细说明

The purpose of this study is to determine whether the combination product, sumatriptan and naproxen sodium, is effective compared to placebo in the treatment of acute migraine in adolescent subjects 12-17 years old. Subjects will treat two migraine attacks over a ~25 week period.

研究类型

介入性

注册 (实际的)

589

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

  • 美国
    • Arizona
      • Gilbert、Arizona、美国、85234
        • GSK Investigational Site
      • Litchfield Park、Arizona、美国、85340
        • GSK Investigational Site
      • Phoenix、Arizona、美国、85013
        • GSK Investigational Site
      • Phoenix、Arizona、美国、85016
        • GSK Investigational Site
      • Phoenix、Arizona、美国、85014
        • GSK Investigational Site
    • Arkansas
      • Conway、Arkansas、美国、72034
        • GSK Investigational Site
      • Little Rock、Arkansas、美国、72205
        • GSK Investigational Site
      • Little Rock、Arkansas、美国、72202
        • GSK Investigational Site
    • California
      • Chico、California、美国、95926
        • GSK Investigational Site
      • Fresno、California、美国、93720
        • GSK Investigational Site
      • Fullteron、California、美国、92835
        • GSK Investigational Site
      • Huntington Beach、California、美国、92647
        • GSK Investigational Site
      • Newport Beach、California、美国、92660
        • GSK Investigational Site
      • Roseville、California、美国、95678
        • GSK Investigational Site
      • Sacramento、California、美国、95816
        • GSK Investigational Site
      • Sacramento、California、美国、95815
        • GSK Investigational Site
      • San Francisco、California、美国、94109
        • GSK Investigational Site
      • Santa Monica、California、美国、90404
        • GSK Investigational Site
    • Colorado
      • Colorado Springs、Colorado、美国、80907
        • GSK Investigational Site
    • Connecticut
      • Fairfield、Connecticut、美国、06824
        • GSK Investigational Site
    • Florida
      • Gainesville、Florida、美国、32607
        • GSK Investigational Site
      • Hialeah、Florida、美国、33010
        • GSK Investigational Site
      • Miami、Florida、美国、33155-3009
        • GSK Investigational Site
      • Pensacola、Florida、美国、32504
        • GSK Investigational Site
      • West Palm Beach、Florida、美国、33407
        • GSK Investigational Site
    • Georgia
      • Atlanta、Georgia、美国、30342
        • GSK Investigational Site
      • Savannah、Georgia、美国、31405
        • GSK Investigational Site
      • Stockbridge、Georgia、美国、30281
        • GSK Investigational Site
    • Illinois
      • Chicago、Illinois、美国、60642
        • GSK Investigational Site
      • Oak Lawn、Illinois、美国、60453
        • GSK Investigational Site
      • Park Ridge、Illinois、美国、60068
        • GSK Investigational Site
    • Indiana
      • Anderson、Indiana、美国、46011
        • GSK Investigational Site
      • Terre Haute、Indiana、美国、47802
        • GSK Investigational Site
    • Kansas
      • Kansas City、Kansas、美国、66160
        • GSK Investigational Site
      • Wichita、Kansas、美国、67207
        • GSK Investigational Site
    • Kentucky
      • Bardstown、Kentucky、美国、40004
        • GSK Investigational Site
      • Lexington、Kentucky、美国、40509
        • GSK Investigational Site
    • Maryland
      • Pikesville、Maryland、美国、21208
        • GSK Investigational Site
    • Massachusetts
      • Worcester、Massachusetts、美国、01605
        • GSK Investigational Site
    • Michigan
      • Ann Arbor、Michigan、美国、48104
        • GSK Investigational Site
    • Minnesota
      • Plymouth、Minnesota、美国、55441
        • GSK Investigational Site
    • Missouri
      • Springfield、Missouri、美国、65807
        • GSK Investigational Site
      • St. Louis、Missouri、美国、63141
        • GSK Investigational Site
    • Nebraska
      • Omaha、Nebraska、美国、68130
        • GSK Investigational Site
    • Nevada
      • Henderson、Nevada、美国、89014
        • GSK Investigational Site
    • New Jersey
      • Vorhees、New Jersey、美国、08043
        • GSK Investigational Site
      • Willingboro、New Jersey、美国、08046
        • GSK Investigational Site
    • New Mexico
      • Albuquerque、New Mexico、美国、87108
        • GSK Investigational Site
    • New York
      • Amherst、New York、美国、14226
        • GSK Investigational Site
      • Mineola、New York、美国、11501
        • GSK Investigational Site
      • Mount Vernon、New York、美国、10550
        • GSK Investigational Site
      • Schenectady、New York、美国、12308
        • GSK Investigational Site
    • North Carolina
      • Raleigh、North Carolina、美国、27607
        • GSK Investigational Site
    • Ohio
      • Cincinnati、Ohio、美国、45229
        • GSK Investigational Site
      • Cincinnati、Ohio、美国、45245
        • GSK Investigational Site
      • Cleveland、Ohio、美国、44195
        • GSK Investigational Site
      • West Chester、Ohio、美国、45069
        • GSK Investigational Site
      • Westerville、Ohio、美国、43081
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73112
        • GSK Investigational Site
    • Oregon
      • Eugene、Oregon、美国、97401
        • GSK Investigational Site
      • Portland、Oregon、美国、97210
        • GSK Investigational Site
      • Salem、Oregon、美国、97301
        • GSK Investigational Site
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19139
        • GSK Investigational Site
      • Pittsburgh、Pennsylvania、美国、15236
        • GSK Investigational Site
    • South Carolina
      • Greer、South Carolina、美国、29651
        • GSK Investigational Site
      • Simpsonville、South Carolina、美国、29681
        • GSK Investigational Site
    • Tennessee
      • Bristol、Tennessee、美国、37620
        • GSK Investigational Site
      • Clarksville、Tennessee、美国、37043
        • GSK Investigational Site
    • Texas
      • Dallas、Texas、美国、75230
        • GSK Investigational Site
      • Houston、Texas、美国、77030-2303
        • GSK Investigational Site
      • San Antonio、Texas、美国、78258
        • GSK Investigational Site
    • Utah
      • Salt Lake City、Utah、美国、84107
        • GSK Investigational Site
    • Virginia
      • Charlottesville、Virginia、美国、22902
        • GSK Investigational Site
      • Norfolk、Virginia、美国、23510
        • GSK Investigational Site
    • Washington
      • Seattle、Washington、美国、98195-6097
        • GSK Investigational Site
      • Vancouver、Washington、美国、98686
        • GSK Investigational Site
      • Wenatchee、Washington、美国、98801
        • GSK Investigational Site
    • Wisconsin
      • Madison、Wisconsin、美国、53715
        • GSK Investigational Site
      • Middleton、Wisconsin、美国、53562-2215
        • GSK Investigational Site

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

12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: Subjects eligible for enrollment in the study must meet all of the following criteria:

  1. Subject is >/=12 years of age and </=17 years of age at the Screening Visit.
  2. Subject has migraine with or without aura (ICHD-II criteria, 1.2.1 or 1.1). A history of at least two, but no more than eight attacks per month, for the six months prior to the Screening Visit is required. Attacks should last a minimum of three hours and be associated with moderate-to-severe headache pain.
  3. Subject is able to distinguish migraine from other headaches (i.e., tension-type headaches).

  4. Male or female subjects. Female subjects are eligible for participation in the study if they are:

    1. Females of non-childbearing potential; or
    2. Females of childbearing potential, and who have a negative urine pregnancy test at screening, and agree to use one of the GlaxoSmithKline (GSK)-specified highly effective methods for avoiding pregnancy
  5. Any subject taking oral contraceptives at enrollment must be on a stable regimen for at least 2 months prior to screening.
  6. Subject and subject's parent or legal guardian are able to read and write English or Spanish.
  7. Subject is able to read, comprehend, and complete subject diaries.
  8. Subject's parent or legal guardian is willing and able to provide Informed Consent prior to subject entry into the study.

  9. Subject is willing and able to provide Informed Assent prior to entry into the study (if required).

    -

Exclusion Criteria:

  • Subjects meeting any of the following criteria must not be enrolled in the study:

    1. Subject is < 74 pounds (33.3 kg).
    2. Subject has ≥15 headache days per month in total (migraine, probable migraine, or tension-type), retinal (ICHD-II 1.4), basilar (ICHD-II 1.2.6), or hemiplegic migraine (ICHD-II 1.2.4), or secondary headaches.
    3. Subject, in the investigator's opinion is likely to have unrecognized cardiovascular or cerebrovascular disease.
    4. Subject has uncontrolled hypertension at screening or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
    5. Subject has a history of congenital heart disease, cardiac arrhythmias requiring medication, or a history of a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in this study.
    6. Subject has evidence or history of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease, or signs/symptoms consistent with any of the above.
    7. Subject has evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower the convulsive threshold, or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening.
    8. Subject has a history of impaired hepatic or renal function that, in the investigator's opinion, contraindicates participation in this study.
    9. Subject has hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan, NSAID, or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma.
    10. Subject has used an ergot medication in the previous three months for migraine prophylaxis or is taking a medication that is not stabilized (i.e., change of dose within the past 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.
    11. Subject has a recent history of regular use of opioids or barbiturates for treatment of their migraine headache and/or other non-migraine pain. Regular use is defined as an average of 4 days per month over the last 6 months.
    12. Subject has taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within the two weeks prior to screening through two weeks post treatment.
    13. Subject has a history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent.
    14. Subject has evidence or history of any gastrointestinal surgery, GI ulceration, or perforation in the past six months, gastrointestinal bleeding in the past year, or evidence or history of inflammatory bowel disease.
    15. Subject is pregnant, actively trying to become pregnant, or breast feeding or subject is not willing to have pregnancy test(s).
    16. Subject tests positive for illicit substances on toxicology screen, or has evidence of alcohol or substance abuse within the last year, or any concurrent medical or psychiatric condition which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical trial.
    17. Subject has participated in any investigational drug trial within the previous 4 weeks or plans to participate in another study at any time during this study.

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：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
安慰剂匹配
药品：安慰剂
安慰剂匹配
实验性的：Sumatriptan and Naproxen 1
Sumatriptan succinate and naproxen sodium combination 10mg/60mg
药品：Sumatriptan and Naproxen Sodium
Sumatriptan succinate and naproxen sodium
实验性的：Sumatriptan and Naproxen 2
Sumatriptan succinate and naproxen sodium combination 30mg/180mg
药品：Sumatriptan and Naproxen Sodium
Sumatriptan succinate and naproxen sodium
实验性的：Sumatriptan and Naproxen 3
Sumatriptan succinate and naproxen sodium combination 85mg/500mg
药品：Sumatriptan and Naproxen Sodium
Sumatriptan succinate and naproxen sodium

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
Number of Participants Who Were Pain Free at 2 Hours Post-dose
大体时间：2 hours after single dose of double-blind treatment (Randomization through Week 13)
Participants were evaluated (self-assessment) for pain intensity by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe. Participants with pain-free response were considered as those who had a reduction in migraine headache pain from moderate (score=2) or severe (score=3) at baseline to none (score=0) post-treatment, without the use of rescue medication (additional medication taken by participants for the treatment of migraine pain or associated symptoms) prior to or at 2 hours post-dose.
2 hours after single dose of double-blind treatment (Randomization through Week 13)

次要结果测量

结果测量
措施说明
大体时间
Number of Participants Sustained Pain-free From 2-24 Hours
大体时间：2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Participants with sustained pain-freedom were defined as those with pain-freedom at 2 hours post-dose that was maintained up to 24 hours post-treatment without the use of rescue medication.
2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Photophobia-free at 2 Hours Post-dose
大体时间：2 hours after single dose of double-blind treatment (Randomization through Week 13)
The number of participants who did not have photophobia (sensitivity to light) at 2 hours post dose was analyzed.
2 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Phonophobia-free at 2 Hours Post-dose
大体时间：2 hours after single dose of double-blind treatment (Randomization through Week 13)
The number of participants who did not have phonophobia (sensitivity to sound) at 2 hours post dose was analzyed.
2 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Pain-free at 1 Hour Post-dose
大体时间：1 hour after single dose of double-blind treatment (Randomization through Week 13)
Participants with a pain-free response at 1 hour post-dose were considered as those who had a reduction in migraine headache pain from moderate (a score of 2) or severe (a score of 3) at baseline to none (a score of 0) post-treatment, without the use of rescue medication prior to or at 1 hour post dose.
1 hour after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Sustained Photophobia-free From 2-24 Hours
大体时间：2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Participants with sustained freedom from photophobia were those with an absence of photophobia (sensitivity to light) from 2 to 24 hours post-dose without the use of rescue medication.
2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Sustained Phonophobia-free From 2-24 Hours
大体时间：2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Participants with sustained freedom from phonophobia were those with an absence of phonophobia (sensitivity to sound) from 2 to 24 hours post-dose without the use of rescue medication.
2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Sustained Nausea-free From 2-24 Hours
大体时间：2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Participants with sustained freedom from nausea were those with an absence of nausea from 2 to 24 hours post-dose without the use of rescue medication.
2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Who Used Rescue Medication From 2 to 24 Hours Post Dose
大体时间：2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with investigational product. Permitted rescue medications included oral naproxen sodium (maximum 15 mg/kg), oral over-the-counter pain reliever, and anti-emetics. This outcome measure included only participants who rescued from 2 to 24 hours post-dose, inclusive.
2 to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Who Used Their First Dose of Rescue Medication Through the Indicated Time Points
大体时间：Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Rescue medication was defined as an additional medication taken by participants for the treatment of migraine pain or associated symptoms within 24 hours of dosing with double-blind treatment. In addition to participants who rescued from 2 to 24 hours post-dose, inclusive, this outcome measure also included nine protocol violators who rescued < 2 hours post-treatment.
Dosing to 24 hours after single dose of double-blind treatment (Randomization through Week 13)
Number of Participants Nausea-free at 2 Hours Post-dose
大体时间：2 hours after single dose of double-blind treatment (Randomization through Week 13)
The number of participants who did not have nausea at 2 hours post dose was analzyed.
2 hours after single dose of double-blind treatment (Randomization through Week 13)

其他结果措施

结果测量
措施说明
大体时间
Mean Age of Participants at Baseline Categorized by Age Group
大体时间：Baseline
The mean age of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.
Baseline
Number of Participants Randomized to Double-blind Treatment in the Indicated Age Categories at Baseline
大体时间：Baseline
The number of participants receiving double-blind treatment were reported according to age.
Baseline
Number of Female and Male Participants Categorized by Age Group
大体时间：Baseline
The gender of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.
Baseline
Number of Participants of the Indicated Race Categorized by Age Group
大体时间：Baseline
The race of participants at baseline was reported for all participants in the 12 to 14 year and 15 to 17 year age groups.
Baseline
Mean Weight of Participants at Baseline Categorized by Age Group
大体时间：Baseline
The mean weight of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups.
Baseline
Mean Body Mass Index of Participants at Baseline Categorized by Age Group
大体时间：Baseline
The mean body mass index of participants at baseline was calculated for all participants in the 12 to 14 year and 15 to 17 year age groups. Body mass index is calculated as: weight (kilograms [kg]) divided by height (meters [m]^2).
Baseline

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

GlaxoSmithKline

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

2008年12月1日

初级完成 (实际的)

2010年5月1日

研究完成 (实际的)

2010年6月1日

研究注册日期

首次提交

2009年2月12日

首先提交符合 QC 标准的

2009年2月12日

首次发布 (估计)

2009年2月13日

研究记录更新

最后更新发布 (估计)

2017年1月18日

上次提交的符合 QC 标准的更新

2016年11月30日

最后验证

2016年11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

  • 107979

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

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

研究数据/文件

  1. 数据集规范
    信息标识符：107979
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  2. 统计分析计划
    信息标识符：107979
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  3. 研究协议
    信息标识符：107979
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  4. 知情同意书
    信息标识符：107979
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  5. 带注释的病例报告表
    信息标识符：107979
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  6. 个人参与者数据集
    信息标识符：107979
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  7. 临床研究报告
    信息标识符：107979
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register

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.

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