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Targin for Non-cancer Pain

2017年11月10日 更新者：Mundipharma (China) Pharmaceutical Co. Ltd

A Randomized, Double-blind, Double-dummy, Parallel-group, Multicenter Study to Demonstrate Improvement in Symptoms of Constipation in Subjects With Moderate to Severe Non-malignant Pain Taking Oxycodone Equivalent of ≥10 mg/Day and ≤50 mg/Day as Oxycodone/Naloxone Prolonged-release (OXN) Compared to Subjects Taking Oxycodone Prolonged-release (OXY) Tablets Alone.

To determine the improvement in symptoms of constipation in subjects receiving treatment with oxycodone/naloxone prolonged release tablets (OXN) compared to oxycodone prolonged release tablets (OXY) based on the Bowel Function Index (BFI)

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)

230

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

  • 中国
      • Beijing、中国
        • Peking University Third Hospital
      • Beijing、中国
        • Peking Union Medical College Hospital
      • Beijing、中国
        • Beijing Friendship Hospital
      • Beijing、中国
        • Beijing Tiantan Hospital
      • Beijing、中国
        • Beijing Union Hospital
      • Bengbu、中国
        • the First Affiliated Hospital of Bengbu Medical Collage
      • Changsha、中国
        • Xiangya Hospital Central South University
      • Changsha、中国
        • The Third XIANGYA Hospital of Central South University
      • Changsha、中国
        • The thrid Xiangya Hospital of central south university
      • Chengdu、中国
        • West China Hospital
      • Chongqing、中国
        • Daping Hospital
      • Chongqing、中国
        • South West hospital
      • Fuzhou、中国
        • Fuzhou General Hospital
      • Guangzhou、中国
        • The third affiliated hospital sun yat-sen university
      • Guizhou、中国
        • Guizhou Provincial People's Hospital
      • Harbin、中国
        • The Second Affiliated Hospital of Harbin Medical University
      • Jinan、中国
        • Shandong Provincial Hospital
      • Shanghai、中国
        • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
      • Shanghai、中国
        • Shanghai Changhai Hospital
      • Shanghai、中国
        • Zhongshan Hospital Fudan University
      • Shanghai、中国
        • Shanghai Sixth People's Hospital
      • Shantou、中国
        • the First Affiliated Hospital of Shantou University Medical College
      • Shenyang、中国
        • The General Hospital of Shenyang Military
      • Wuhan、中国
        • The Central Hospital of Wuhan
      • Wuhan、中国
        • Tongji Hospital
      • Wuhan、中国
        • Union Hospital Tongji Medical College
      • Xuzhou、中国
        • The Affiliated Hospital of Xuzhou Medical University
      • Zhejiang、中国
        • Second Affiliated Hospital of Zhejiang University
    • Guangdong
      • Guangzhou、Guangdong、中国
        • Guangzhou First People's Hospital
      • Shan Tou、Guangdong、中国
        • Second Affiliated Hospital of Shan Tou University Medical College
    • Hebei
      • Shijiazhuang、Hebei、中国
        • Hebei General Hospital

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

全部

描述

Screening Inclusion criteria:

  • Males or females, 18 years of age or older
  • Clinical diagnosis of musculo-skeletal pain for 4 weeks or longer with non-malignant pain etiology at Visit 1. Possible etiologies are conditions related to intervertebral disc disease, spondylolisthesis and osteoarthritis; other similar non-malignant diseases are also eligible.
  • Patients with non-malignant pain that require around-the-clock opioid therapy (oxycodone equivalent of ≥10 mg/day and ≤50 mg/day) who are likely to benefit from WHO step III opioid therapy for the duration of the study
  • Patients who have been already treated with NSAIDs at least 2 weeks before enrolment are also eligible, but they should rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as ≥4 on 0-10 scale."
  • Subjects are either taking opioid medication or willing to take opioids to treat their pain
  • Patients who are willing to use adequate and reliable contraception throughout the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectable, combined oral contraceptives, some IUDs (intrauterine Device, hormonal), sexual abstinence or vasectomized partner
  • Subjects willing and able to participate in all aspects of the study, including use of oral medication, completion of subjective evaluations, attending scheduled clinic visits, completing telephone contacts, and compliance with protocol requirements are evidenced by providing written informed consent

  • Subjects taking pre-study, non-opioid analgesics, and all other concomitant medications, including those medications for the treatment of depression and are considered necessary for the subject's welfare, and are anticipated to remain stable throughout the double-blind period of the study, and are to be continued under the supervision of the investigator, are eligible.

    • Patients who have been already treated with NSAIDs at least 2 weeks before enrolment are also eligible, but they should rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as ≥4 on 0-10 scale.

Criteria for entry to the Double-Blind phase:

  1. Subjects continue to satisfy screening criteria outlined in the protocol
  2. Subject's OXY dose is between 10-50 mg/day
  3. Subjects who rate their pain (Pain Intensity Scale -"average pain" over the last 24 hours) as≤4 on 0-10 scale with less than or equal to two doses of Morphine Sulfate tablets rescue medication per day for either the last three consecutive days or four of the last seven days

  4. Subjects who have constipation induced, or worsened by their opioid study medication, as shown by:

    1. The subject's medical need for regular intake of laxatives to have at least 3 bowel evacuations per week, or having less than 3 bowel evacuations per week when not taking a laxative, respectively and
    2. The subjects' constipation was considered to be induced, worsened or maintained by their current study opioid medication and
    3. BFI value > 30.
  5. Subjects demonstrate compliance with laxative use, and completing appropriate and legible daily diaries
  6. Subjects taking daily fibre supplementation or bulking agents are eligible if they can be maintained on a stable dose and regimen throughout the study, and in the investigator's opinion are willing and able to maintain adequate hydration.

Screening Exclusion criteria:

  1. Females who are pregnant (positive β-hCG test) or lactating
  2. Any history of hypersensitivity or with any contraindication to oxycodone, naloxone, bisacodyl, or related products
  3. Subjects currently taking the equivalent of > 50 mg/day Oxycodone PR
  4. Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal (paralytic ileus), or psychiatric disease, as determined by medical history, clinical laboratory tests, electrocardiogram (ECG) results, and physical examination, that will place the subject at risk upon exposure to the study medication or that could confound the analysis and/or interpretation of the study results
  5. Subjects with evidence of impaired liver/kidney function upon entry into the study defined as aspartate aminotransferase (AST; SGOT), alanine aminotransferase (ALT; SGPT), or alkaline phosphatase levels >3 times the upper limit of normal; gamma glutamyltranspeptidase (GGT or GGTP) ≥ 5 times the upper limit of normal; total bilirubin level outside of the reference range; and/or creatinine level outside of the reference range or >2 mg/dl, or in the investigator's opinion, liver and/or kidney impairment to the extent that the subject should not participate in this study
  6. Subjects with evidence of significant structural abnormalities of the gastrointestinal tract or any diseases/conditions that affect bowel transit
  7. Subjects who have required treatment for the diagnosis of irritable bowel syndrome (IBS)
  8. Subjects receiving hypnotics or other central nervous system (CNS) depressants that, in the investigator's opinion, may pose a risk of additional CNS depression with opioids study medication
  9. Surgery within 2 months prior to the start of the Screening Period, or planned surgery during the 12-week Double-blind Phase that may have affected GI motility or pain
  10. Subjects diagnosed with cancer, not including basal cell carcinoma
  11. Subjects with Rheumatoid Arthritis (RA)
  12. Subjects receiving opioid substitution therapy for opioid addiction (e.g., methadone or buprenorphine)
  13. Subjects with active alcohol or drug abuse and/or history of opioid abuse
  14. Subjects who participated in a clinical research study involving a new chemical entity or an experimental drug within 30 days of study entry (defined as the start of the Screening Period)
  15. Subjects presently taking, or who had taken naloxone or naltrexone within 30 days of study entry (defined as the start of the Screening Period).

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
实验性的：Oxycodone/naloxone prolonged release tablets
Dose strength:5/2.5 mg,10/5mg, 20/10mg,PO,q12h.daily dose from 10/5mg to 50/25mg.treatment duration:12 weeks
药品：Oxycodone/naloxone prolonged release tablets
有源比较器：Oxycodone prolonged release tablets
Dose strength:5mg,10mg, 20mg,PO,q12h.daily dose from 10mg to 50mg.treatment duration:12 weeks
药品：Oxycodone/naloxone prolonged release tablets

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Bowel function index(BFI) 12 Weeks
大体时间：12 weeks
12 weeks

次要结果测量

结果测量
大体时间
Modified BPI-SF-Average Pain over the last 24 hours
大体时间：12 weeks
12 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

Mundipharma (China) Pharmaceutical Co. Ltd

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 (实际的)

2013年9月1日

初级完成 (实际的)

2017年3月30日

研究完成 (实际的)

2017年3月30日

研究注册日期

首次提交

2013年8月5日

首先提交符合 QC 标准的

2013年8月6日

首次发布 (估计)

2013年8月7日

研究记录更新

最后更新发布 (实际的)

2017年11月14日

上次提交的符合 QC 标准的更新

2017年11月10日

最后验证

2017年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • OXN08-CN-302a

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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