EUCTR2008-003592-48-BG进行中（未招募）不适用
A double-blind, multi-centre, reference-controlled, randomised Phase III study to compare the analgesic efficacy and tolerability of a buprenorphine transdermal system in two different application intervals using three different dosages (35, 52.5, or 70 µg/h) in patients with chronic, severe cancer pain inadequately controlled with other analgesics
ovosis AG0 个研究点目标入组 100 人开始时间: 2009年1月12日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.1Inclusion criteria
- •The patient is suffering from chronic, severe cancer pain and requires opioid treatment
- •The patient is aged between 18 and 75 years
- •The patient is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the Consent Form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Clinically relevant increasing daily doses of the non-opioid and opioid
- •analgesic medication in the last 14 days prior to the start of the study and in the
- •course of the study
- •Intake of any other strong opioids (step 3 WHO-Guidelines) in the course of
- •Clinically relevant increasing daily doses of co-analgesics, e.g. steroids,
- •anticonvulsants and antidepressants in the last 14 days prior to the start of the
- •study and in the course of the study
- •Non-pharmacological pain therapies, e.g. neurolysis, acupuncture, epidural
- •anaesthesia
- •Planned surgery in the next 30 days or in the last 14 days prior to the start of
- •Any treatment which in the opinion of the responsible physician might have a
- •clinically relevant influence on pain intensity
- •Patients with clinically significant impaired renal or hepatic function
- •Study Code: BUP/006/C / Protocol Version Number: 4 / 2008/ 11th November Page 26
- •Patients with a clinically relevant impairment of respiratory function including
- •presence or history of chronic obstructive lung disorder or any other serious
- •lung disease
- •Pregnancy or lactation
- •Women with child-bearing potential who do not apply a medically accepted
- •safe method of contraception (e.g. sterilisation, oral contraception)
- •Known alcoholism or drug abuse
- •Patients with a known or suspected history of abuse of centrally acting
- •Patients with increased intracranial pressure including metastases in the CNS
- •which could lead to respiratory depression
- •Present febrile state and regionally increased body temperature which could
- •lead to increased plasma concentrations of buprenorphine
- •The subject or his family has a history of non-allergic drug reactions, of a drug
- •allergy, or other allergy, which in the opinion of the responsible physician
- •contraindicates the subject's participation in the study
- •The subject has a known or suspected personal history or family history of
- •adverse reactions or hypersensitivity to buprenorphine or buprenorphine-like
- •Treatment with monoamine oxidase inhibitors in the last 14 days prior to the
- •start of the active treatment phase
- •Patients suffering from myasthenia gravis
- •Significant skin lesions on arms (or other chosen area for patch application) or
- •diffuse skin disease (e.g. diffuse psoriasis or eczema)
- •Subjects with a medical disorder, condition or history of such that would
- •impair the subject’s ability to participate or complete this study in the opinion
- •of the investigator
- •Participation in another clinical trial within one month prior to enrolment or
- •during the course of the study
- •Relevant pathological changes in the ECG.
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