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Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids

2013年1月17日 更新者：Takeda

A Phase II, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of TAK-385 10, 20, and 40 mg (p.o.) in the Treatment of Uterine Fibroids

The purpose of this study is to determine the efficacy and safety of TAK-385, once daily (QD), for 12 weeks in women with uterine fibroids.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This study is a Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled for evaluation of the efficacy and safety of TAK-385 10, 20, and 40 mg (p.o.) following once daily administration for 12 weeks in women with uterine fibroids.

研究类型

介入性

注册 (实际的)

216

阶段

  • 阶段2

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

  • 日本
    • Chiba
      • Chiba-shi、Chiba、日本
      • Itchihara-shi、Chiba、日本
      • Matsuno-shi、Chiba、日本
    • Ehime
      • Matsuyama-shi、Ehime、日本
      • Nihama-shi、Ehime、日本
    • Fukui
      • Fukui-shi、Fukui、日本
    • Fukuoka
      • Fukuoka-shi、Fukuoka、日本
      • Iizuka-shi、Fukuoka、日本
      • Yanagigawa-shi、Fukuoka、日本
    • Gunma
      • Mebashi-shi、Gunma、日本
    • Hokkaido
      • Ebetsu-shi、Hokkaido、日本
      • Sapporo-shi、Hokkaido、日本
    • Hyogo
      • Amagasaki-shi、Hyogo、日本
      • Kobe-shi、Hyogo、日本
    • Kanagawa
      • Kamakura-shi、Kanagawa、日本
      • Yokohama-shi、Kanagawa、日本
    • Oita
      • Oita-shi、Oita、日本
    • Osaka
      • Ibaraki-shi、Osaka、日本
      • Osaka-shi、Osaka、日本
      • Sakai-shi、Osaka、日本
      • Tondabayashi-shi、Osaka、日本
    • Tokyo
      • Chuo-ku、Tokyo、日本
      • Itabashi-ku、Tokyo、日本
      • Setagaya-ku、Tokyo、日本
      • Shinagawa-ku、Tokyo、日本
      • Suginami-ku、Tokyo、日本
    • Toyama
      • Toyama-shi、Toyama、日本

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

20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:

  1. The participant has been diagnosed with uterine fibroids and has never received surgical treatment for the myoma.
  2. The participant is a premenopausal woman.
  3. The participant has one or more measurable noncalcified myomas confirmed by transvaginal sonography.
  4. The participant has experienced regular menstrual cycles
  5. The participant is diagnosed as menorrhagia

Exclusion Criteria:

  1. Participants with a screening Hb <8 g/dL
  2. Participants with a previous or current history of blood disorders
  3. Participants with a known history of severe hypersensitivity or severe allergy to sanitary goods
  4. Participants with lower abdominal pain due to irritable bowel syndrome or severe interstitial cystitis
  5. Participants with a previous or current history of thyroid dysfunction
  6. Participants with a previous or current history of pelvic inflammatory disease
  7. Participants with a positive PAP smear test result
  8. Participants with a history of panhysterectomy or bilateral oophorectomy
  9. Participants judged by investigator to have marked abnormal uterine bleeding or anovulatory bleeding
  10. Participants with a previous or current history of a malignant tumor
  11. Participants who have been treated with any of the following drugs: anticoagulant drug, antiplatelet drug, tranexamic acid, selective estrogen receptor modulator (SERM), activated vitamin D, other vitamin D, calcitonin, ipriflavone, steroid hormone, vitamin K, teriparatide, or denosumab
  12. Participants who have been treated with any of the following drugs: oral contraceptive and sex hormone preparation, gonadotropin-releasing hormone (GnRH) analogue, dienogest, danazol, or aromatase inhibitor
  13. Participants who have been treated with a bisphosphonate preparation
  14. Participants with a previous or current history of severe hypersensitivity or severe allergy to drugs
  15. Participants with non-diagnosable abnormal genital bleeding
  16. Participants with a previous or current history of osteoporosis, bone mass loss, or other metabolic bone diseases
  17. Participants with clinically significant cardiovascular disease or uncontrollable hypertension
  18. Participants judged by investigator to be inappropriate to participate in this study based on the 12-lead electrocardiogram (ECG) findings
  19. Participants with active liver disease or jaundice, or with alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin > 1.5 times the upper limit of normal (ULN)

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
安慰剂比较：安慰剂
药品：Placebo
TAK-385 placebo-matching tablets, orally, once daily for up to 12 weeks.
实验性的：TAK-385 10 毫克 QD
药品：TAK-385
TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.
药品：TAK-385
TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.
药品：TAK-385
TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.
实验性的：TAK-385 20 毫克 QD
药品：TAK-385
TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.
药品：TAK-385
TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.
药品：TAK-385
TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.
实验性的：TAK-385 40 毫克 QD
药品：TAK-385
TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.
药品：TAK-385
TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.
药品：TAK-385
TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.

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
Decrease in menstrual blood loss
大体时间：Week 12 (one menstrual cycle)
Blood loss will be assessed using the Pictorial Blood Loss Assessment Chart (PBAC).
Week 12 (one menstrual cycle)

次要结果测量

结果测量
措施说明
大体时间
骨密度
大体时间：直到第 12 周。
通过双能 X 射线吸收法 (DXA) 测量
直到第 12 周。
体重
大体时间：直到第 12 周。
直到第 12 周。
Decrease in menstrual blood loss
大体时间：Up to Week 6
Blood loss will be assessed using PBAC
Up to Week 6
Decrease in menstrual blood loss
大体时间：Up to Week 12.
Blood loss will be assessed using PBAC
Up to Week 12.
Amenorrhea
大体时间：Week 12 (one menstrual cycle).
Amenorrhea will be assessed using PBAC
Week 12 (one menstrual cycle).
Amenorrhea
大体时间：Up to Week 6.
Amenorrhea will be assessed using PBAC
Up to Week 6.
Amenorrhea
大体时间：Up to Week 12.
Amenorrhea will be assessed using PBAC
Up to Week 12.
Change in menstrual blood loss
大体时间：Week 12 (one menstrual cycle)
Change in menstrual blood loss measured by PBAC
Week 12 (one menstrual cycle)
Myoma Volume
大体时间：Up to Week 12.
Up to Week 12.
Uterine Volume
大体时间：Up to Week 12.
Up to Week 12.
Hemoglobin Concentration in Blood
大体时间：Up to Week 12.
Up to Week 12.
Pain Symptom
大体时间：Up to Week 12.
Measured by Numerical Rating Scale.
Up to Week 12.
Other Clinical Symptoms
大体时间：Up to Week 12.
Assessed by clinical laboratory tests
Up to Week 12.
Quality of Life (QOL) Score
大体时间：Up to Week 12.
QOL will be assessed using Uterine Fibroid Symptom and Quality of Life (UFS-QOL)
Up to Week 12.
Treatment-emergent Adverse Events
大体时间：Up to Week 16.
Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through the last visit (Week 16)
Up to Week 16.
Vital Signs
大体时间：Up to Week 12.
Vital signs will include body temperature, sitting blood pressure, and pulse (bpm).
Up to Week 12.
Electrocardiograms
Up to Week 12.
Laboratory Values
大体时间：Up to Week 12
Up to Week 12
Serum NTx
大体时间：Up to Week 12
NTx is one of the biochemical bone metabolism markers
Up to Week 12
Serum BAP
大体时间：Up to Week 12
BAP is one of the biochemical bone metabolism markers
Up to Week 12

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

Takeda

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

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10月1日

初级完成 (实际的)

2012年9月1日

研究完成 (实际的)

2012年9月1日

研究注册日期

首次提交

2011年8月31日

首先提交符合 QC 标准的

2011年10月12日

首次发布 (估计)

2011年10月17日

研究记录更新

最后更新发布 (估计)

2013年1月21日

上次提交的符合 QC 标准的更新

2013年1月17日

最后验证

2013年1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

  • TAK-385/CCT-001
  • U1111-1123-6815 (注册表标识符：WHO)
  • JapicCTI-111590 (注册表标识符：JapicCTI)

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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