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Casopitant And ZOFRAN To Prevent Post Operative Nausea And Vomiting In Women

2017年3月21日 更新者：GlaxoSmithKline

A Phase III Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of the 30 mg Intravenous Formulation of the Neurokinin-1 Receptor Antagonist GW679769 for Prevention of Postoperative Nausea and Vomiting in Female Subjects at High Risk for Emesis

This study is being conducted to see if adding GW679769 (casopitant) to ZOFRAN will significantly decrease the number of patients who experience nausea and vomiting after surgery.

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)

515

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

  • 俄罗斯联邦
      • Moscow、俄罗斯联邦、101000
        • GSK Investigational Site
      • Moscow、俄罗斯联邦、111538
        • GSK Investigational Site
      • Moscow、俄罗斯联邦、117152
        • GSK Investigational Site
      • Perm、俄罗斯联邦、614107
        • GSK Investigational Site
      • St. Petersburgh、俄罗斯联邦、192242
        • GSK Investigational Site
  • 加拿大
    • Ontario
      • Toronto、Ontario、加拿大、M5G 2M9
        • GSK Investigational Site
      • Toronto、Ontario、加拿大、M5G 1X5
        • GSK Investigational Site
    • Quebec
      • Sainte-Foy、Quebec、加拿大、G1V 4G2
        • GSK Investigational Site
      • Sherbrooke、Quebec、加拿大、J1H 5N4
        • GSK Investigational Site
  • 巴基斯坦
      • Lahore、巴基斯坦
        • GSK Investigational Site
  • 德国
    • Baden-Wuerttemberg
      • Freiburg、Baden-Wuerttemberg、德国、79110
        • GSK Investigational Site
    • Hessen
      • Marburg、Hessen、德国、35043
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Neubrandenburg、Mecklenburg-Vorpommern、德国、17036
        • GSK Investigational Site
      • Rostock、Mecklenburg-Vorpommern、德国、18059
        • GSK Investigational Site
      • Schwerin、Mecklenburg-Vorpommern、德国、19055
        • GSK Investigational Site
      • Wismar、Mecklenburg-Vorpommern、德国、23966
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Ludwigshafen、Rheinland-Pfalz、德国、67063
        • GSK Investigational Site
    • Saarland
      • Homburg、Saarland、德国、66421
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Halle、Sachsen-Anhalt、德国、06120
        • GSK Investigational Site
    • Schleswig-Holstein
      • Kiel、Schleswig-Holstein、德国、24105
        • GSK Investigational Site
  • 捷克共和国
      • Brno、捷克共和国、625 00
        • GSK Investigational Site
      • Jihlava、捷克共和国、586 01
        • GSK Investigational Site
      • Olomouc、捷克共和国、775 20
        • GSK Investigational Site
      • Pardubice、捷克共和国、532 03
        • GSK Investigational Site
      • Praha 2、捷克共和国、128 51
        • GSK Investigational Site
      • Praha 5、捷克共和国、150 08
        • GSK Investigational Site
  • 比利时
      • Aalst、比利时、9300
        • GSK Investigational Site
      • Brasschaat、比利时、2930
        • GSK Investigational Site
      • Bruxelles、比利时、1200
        • GSK Investigational Site
      • Gent、比利时、9000
        • GSK Investigational Site
  • 泰国
      • Bangkok、泰国
        • GSK Investigational Site
  • 美国
    • Alabama
      • Fairhope、Alabama、美国、36532
        • GSK Investigational Site
      • Mobile、Alabama、美国、36608
        • GSK Investigational Site
      • Montgomery、Alabama、美国、36106
        • GSK Investigational Site
    • Arkansas
      • Little Rock、Arkansas、美国、72205
        • GSK Investigational Site
    • California
      • Arcadia、California、美国、91007
        • GSK Investigational Site
      • Glendale、California、美国、91206
        • GSK Investigational Site
      • Laguna Hills、California、美国、92653
        • GSK Investigational Site
      • Pasadena、California、美国、91105
        • GSK Investigational Site
    • Florida
      • Boca Raton、Florida、美国、33067
        • GSK Investigational Site
      • Melbourne、Florida、美国、32901
        • GSK Investigational Site
      • Miami、Florida、美国、33143
        • GSK Investigational Site
      • West Palm Beach、Florida、美国、33409
        • GSK Investigational Site
    • Illinois
      • Chicago、Illinois、美国、60637
        • GSK Investigational Site
    • Kansas
      • Kansas City、Kansas、美国、66160
        • GSK Investigational Site
    • Maryland
      • Baltimore、Maryland、美国、21229-5299
        • GSK Investigational Site
    • Michigan
      • Royal Oak、Michigan、美国、48073
        • GSK Investigational Site
    • New York
      • Mineola、New York、美国、11501
        • GSK Investigational Site
      • New Hyde Park、New York、美国、11040
        • GSK Investigational Site
      • New York、New York、美国、10038
        • GSK Investigational Site
    • North Carolina
      • Winston-Salem、North Carolina、美国、27103
        • GSK Investigational Site
    • Ohio
      • Cincinnati、Ohio、美国、45208
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
        • GSK Investigational Site
    • Virginia
      • Charlottesville、Virginia、美国、22908
        • GSK Investigational Site
      • Winchester、Virginia、美国、22601
        • GSK Investigational Site
    • Washington
      • Seattle、Washington、美国、98195
        • GSK Investigational Site
  • 菲律宾
      • Manila、菲律宾、1000
        • GSK Investigational Site
      • Quezon, City、菲律宾、1104
        • GSK Investigational Site
  • 西班牙
      • Badalona、西班牙、08916
        • GSK Investigational Site
      • Barcelona、西班牙、08025
        • GSK Investigational Site
      • Barcelona、西班牙、08035
        • GSK Investigational Site
      • Barcelona、西班牙、08003
        • GSK Investigational Site
      • La Coruña、西班牙、15006
        • GSK Investigational Site
      • Mataro、西班牙、08034
        • GSK Investigational Site
      • Pamplona、西班牙、31008
        • GSK Investigational Site
      • Santiago de Compostela、西班牙、15706
        • GSK Investigational Site
  • 香港
      • Kwun Tong、香港
        • GSK Investigational Site
      • Pokfulam、香港
        • GSK Investigational Site
      • Shatin, New Territories、香港
        • GSK Investigational Site
      • Sheung Shui, New Territories、香港
        • 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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion criteria:

  • History of PONV (postoperative nausea and vomiting) and/or motion sickness.
  • Have not smoked for the last 6 months.
  • Having certain abdominal, breast, thyroid or shoulder surgery.

Exclusion criteria:

  • Pregnant or breastfeeding.
  • Have certain pre-existing medical conditions or take certain medications.

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：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

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 achieved a complete response
大体时间：Up to 24 hours
Complete response defined as no vomiting or retching and no rescue therapy during the first 24 hours following placement of the last suture/staple. Vomiting defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit that is not productive of gastrointestinal contents (also known as "dry heaves"). Study participants who receive antiemetic rescue medication(s) during the initial 24 hours was considered treatment failures.
Up to 24 hours

次要结果测量

结果测量
措施说明
大体时间
The severity of nausea experienced by participants in each cohort during the 2, 6, 24 and 48 hour periods, as assessed by an 11-point, linear, numerical rating scale referred to as a "0-10 Likert scale"
大体时间：Up to 48 hours
Nausea is defined as a subjectively unpleasant sensation associated with the awareness of the urge to vomit; the desire to vomit without the presence of expulsive muscular movements. Each participant completed a Likert scale at 2, 6, 24 and 48 hours after placement of the last suture/staple. The Likert scale used a range of 0-10, where 0 = no nausea and 10 = nausea as bad as it could be.
Up to 48 hours
The severity of nausea experienced by participants in each cohort during the 2, 6, 24 and 48 hour periods, as assessed by a categorical scale (none, mild, moderate or severe), as defined in the protocol
大体时间：Up to 48 hours
Nausea is defined as a subjectively unpleasant sensation associated with the awareness of the urge to vomit; the desire to vomit without the presence of expulsive muscular movements. Each participant completed a categorical scale at 2, 6, 24 and 48 hours after placement of the last suture/staple. In the categorical scale, each participant asked to rate the severity of nausea as, none: no nausea, mild: queasiness/upset stomach that is manageable and minimally (if at all) affects daily activities, moderate: increased queasiness, sometimes with the feeling of having to vomit (but not vomiting), that has a significant negative effect on daily activities (for example, being unable to work, eat and drink, prepare food, care for children or others), severe: feeling sick and vomiting or feeling like you are going to vomit, and unable to perform most daily activities.
Up to 48 hours
Number of participants with first emetic event
大体时间：Up to 48 hours
Up to 48 hours
Number of participants with first antiemetic rescue medication
大体时间：Up to 48 hours
Up to 48 hours
Participant satisfaction with the prophylactic antiemetic regimens, as assessed by participant satisfaction assessments in the participant diary
大体时间：Up to 48 hours
Up to 48 hours
Participant willingness of participants to use the same treatment regimen for future surgical procedures, as assessed by participant satisfaction assessments in the participant diary
大体时间：Up to 48 hours
Up to 48 hours
Number of participants with chemistry data outside the reference range
大体时间：Up to 48 hours
Up to 48 hours
Number of participants with hematology data outside the reference range
大体时间：Up to 48 hours
Up to 48 hours
Safety and tolerability of the antiemetic regimens, assessed by clinical observation (including time to awakening from anesthesia, defined as ability to respond to a verbal command)
大体时间：Up to 24 hours
Up to 24 hours
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
大体时间：Up to Days 6-14 visit
An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. Refer to the general AE/SAE module for a list of AEs and SAEs.
Up to Days 6-14 visit

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。

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

2006年3月1日

初级完成 (实际的)

2006年7月1日

研究完成 (实际的)

2006年7月1日

研究注册日期

首次提交

2006年6月2日

首先提交符合 QC 标准的

2006年6月2日

首次发布 (估计)

2006年6月6日

研究记录更新

最后更新发布 (实际的)

2017年3月23日

上次提交的符合 QC 标准的更新

2017年3月21日

最后验证

2017年3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

  • NKT102552

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：NKT102552
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  2. 个人参与者数据集
    信息标识符：NKT102552
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  3. 带注释的病例报告表
    信息标识符：NKT102552
    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：NKT102552
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  5. 研究协议
    信息标识符：NKT102552
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  6. 临床研究报告
    信息标识符：NKT102552
    信息评论：For additional information about this study please refer to the GSK Clinical Study Register
  7. 统计分析计划
    信息标识符：NKT102552
    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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