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The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement

2013年11月20日更新者：Janssen Korea, Ltd., Korea

The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement: Multicenter, Prospective, Open-label, Observational Study

The purpose of this study is to assess the effectiveness and tolerability of Fentanyl matrix in chronic non-cancer pain.

研究概览

地位

完全的

条件

慢性疼痛

干预/治疗

药品：Fentanyl matrix

详细说明

This is a multicenter, prospective (a study in which the patients are identified and then followed forward in time for the outcome of the study), open-label (all people know the identity of the intervention), observational study intended to examine the effectiveness of Fentanyl matrix through the degree of improvement of pain. Fentanyl matrix is a transdermal (through the skin) system providing continuous delivery of fentanyl for 72 hours. Fentanyl matrix will be administered to patients with chronic (prolonged) non-cancer pain under routine practice during 12 weeks. Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.

研究类型

观察性的

注册 (实际的)

410

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

大韩民国
- - Andong、大韩民国
  - Busan、大韩民国
  - Daegu、大韩民国
  - Daejeon、大韩民国
  - Goyang、大韩民国
  - Incheon、大韩民国
  - Jeonju-Si、大韩民国
  - Kwangiu、大韩民国
  - Kwanju、大韩民国
  - Seoul、大韩民国
  - Wonju-Si、大韩民国

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

全部

取样方法

非概率样本

研究人群

Patients who complain of chronic pain and have pain inadequately controlled by previous treatment with narcotic analgesics (eg, tramadols, codeines, morphines, oxycodone), and are judged to require Fentanyl matrix administration will participate in this study.

描述

Inclusion Criteria:

Complain of chronic non-cancer pain that persists for >= 3 months
Pain inadequately controlled by previous treatment with narcotic analgesics (opium or opium-like compounds with potent analgesic effects, eg, tramadol, codeine, morphine, oxycodone)
Women must be postmenopausal, surgically sterile, abstinent, or practicing an effective method of birth control if they have childbearing potential
Male patients who agree to use a method of birth control and not to donate sperm for 1 month after the last dose of the study drug
A written informed consent for study participation

Exclusion Criteria:

Experience of treatment with Fentanyl matrix within the past 4 weeks
No previous experience of use of narcotic analgesics
Past or current history of alcohol or drug abuse
Cannot use transdermal analgesics due to skin disorder
Have serious psychiatric disorder and cannot complete overall study procedures and questionnaire in the judgment of the investigator

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

团体/队列数

队列和干预

团体/队列	干预/治疗
芬太尼基质	药品：Fentanyl matrix Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.

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
The percentage of patients with mean % Pain Intensity Difference (%PID) >= 50% from baseline to endpoint 大体时间：12 weeks	Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).	12 weeks

次要结果测量

结果测量	措施说明	大体时间
The change from baseline in mean pain intensity 大体时间：Baseline, Week 12	Pain intensity will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).	Baseline, Week 12
The difference between the patient's pain treatment goal set at baseline 大体时间：Baseline, Week 12	The degree of pain the patient wishes to achieve by the end of treatment, set at baseline. The degree of pain will be measured using a numeric rating scale (NRS), from 0 (no pain) to 10 (worst pain imaginable).	Baseline, Week 12
The degree of night sleep disturbance due to pain 大体时间：12 weeks	Sleep disturbance due to pain will be measured using a Numeric Rating Scale (NRS): 1 = None, 10 = Complete.	12 weeks
The degree of Interference with Daily Life Performance due to Pain 大体时间：12 weeks	The degree of interference with daily life performance due to pain will be assessed on a 5-point scale: 1 = No interference, 5 = Great interference. Daily life performance means household work performance, etc.	12 weeks
The degree of Interference with Social Life Performance due to Pain 大体时间：12 weeks	The degree of interference with social life performance due to pain will be measured on a 5-point scale; 1 = No interference, 5 = Great interference. Social life performance means interpersonal relationship, going out, working life, etc.	12 weeks
The patient's global assessment of pain treatment 大体时间：12 weeks	The patient will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been in the judgment of the study participant.	12 weeks
The investigator's global assessment of pain treatment 大体时间：12 weeks	The investigator will assess on a 5-point scale (1= not effective, 5= greatly effective) how effective the study drug has been for a patient, in the judgment of the investigator.	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

Janssen Korea, Ltd., Korea

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12月1日

初级完成 (实际的)

2013年3月1日

研究完成 (实际的)

2013年3月1日

研究注册日期

首次提交

2012年9月17日

首先提交符合 QC 标准的

2012年9月17日

首次发布 (估计)

2012年9月20日

研究记录更新

最后更新发布 (估计)

2013年11月21日

上次提交的符合 QC 标准的更新

2013年11月20日

最后验证

2013年11月1日

The Effectiveness and Tolerability of Fentanyl Matrix in Chronic Non-cancer Pain; Assessment of Patient's Pain Treatment Goal Achievement