EUCTR2005-000613-35-HU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 two buprenorphine transdermal systems 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 160 人开始时间: 2005年6月24日最近更新:
适应症
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
- 160
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
- •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
- •·The patient is able to understand and follow instructions and is able to participate in the study for the entire period
- •·Patients must have given their written informed consent to participate in the study after receiving satisfactory previous information and prior to any study specific procedures.
- •Are the trial subjects under 18?
- •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
- •Increasing daily doses of non-opioid and opioid analgesic medication in the last 14 days prior to and during the study
- •·Intake of any other strong opioids (step 3 WHO-Guidelines)
- •·Increasing daily doses of co-analgesics, e.g. steroids, anticonvulsants and antidepressants in the last 14 days prior to and during the study
- •·Non-pharmacological pain therapies·
- •Surgery, radiation, or chemotherapy in the last 14 days prior to the study and in the next 30 days
- •·Patients with clinically significant impaired renal or hepatic function, or with a clinically relevant impairment of respiratory function·
- •·Pregnancy or lactation
- •·Women with child-bearing potential
- •·Known alcoholism or drug abuse
- •·Patients with increased intracranial pressure
- •·History of non- allergic or allergic drug reactions, hypersensitivity to buprenorphine or buprenorphine-like substances
- •·Treatment with monoamine oxidase inhibitors in the last 14 days prior to the start of the active treatment phase
- •·Patients suffering from myasthenia gravis
- •·Relevant pathological changes in the ECG.
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