EUCTR2004-001069-17-LT进行中（未招募）不适用
A double-blind, active-controlled, randomized, multicenter, parallel-group 2 day comparison of 1000 mg propyphenazone / 80 mg codeine (applied as two suppositories) combination therapy versus a 1000 mg propyphenazone monotherapy (applied as two suppositories) in terms of safety and efficacy in patients suffering from urogenital or biliary pain
ovartis Pharma GmbH0 个研究点目标入组 400 人开始时间: 2005年1月31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
- 400
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
- •? patients with at least moderate to severe urogenital or biliary pain (VAS > 60 mm), at least 18 years of age
- •? written informed consent prior to study medication
- •? indication for medicamentous therapy of the urogenital or biliary pain
- •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
- •? pregnancy or breast feeding
- •? female patients in childbearing age without medically approved method of contraception
- •? patients who had any spasmolytic or analgesic treatment because of the current urogenital or biliary pain before entry in the study
- •? known drug related allergies or hypersensitivity, especially towards one of the compounds of the study drugs or rescue medication (propyphenazone or codeine or metamizole)
- •? known allergy or hypersensitivity towards non-steroidal antiphlogistics or acetylsalicylic acid
- •? acute intermittent porphyria
- •? chronic constipation
- •? paralytic intestinal obstruction
- •? glucose-6-phosphase-deficiency
- •? patients with asthma or hay fever
- •? alcohol or drug abuse
- •? tachyarrhythmia
- •? hypotension
- •? intake of antidepressants, MAO-inhibitors, amantadines and neuroleptics, opiadagonists, pancuronium and vecuronium, centrally sedating pharmaceutics
- •? intake of other investigational drugs within the last 30 days before the participation of this trial
研究者
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