EUCTR2007-002784-27-DE进行中（未招募）不适用
Randomised, double-blind, prospective multi-centre study to compare the analgesic efficacy and safety of a paracetamol/codeine/caffeine fixed-dose combination (Azur® compositum) with paracetamol/codeine (Azur® compositum SC) in patients with moderate pain after third molar dental surgery - Azurcomp-Molar
Steiner & Co. Deutsche Arzneimittelgesellschaft mbH & Co. KG0 个研究点开始时间: 2007年11月9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
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 patients will only be included in the trial if they meet all of the following criteria:
- •Male and female outpatients aged 18 years and above
- •X-ray confirmed diagnosis of impacted third molar
- •Ability to swallow tablets
- •Willingness to abstain from caffeinated drinks and food on the day of the surgery
- •Sufficient knowledge of German language to understand trial instructions and rating scales
- •Written informed consent prior to enrolment
- •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
- •The patients will only be included in the trial if they do not meet any of the following criteria:
- •Adolescents < 18 years
- •Hypersensitivity to paracetamol, caffeine, codeine or any other ingredients of the investigational medicinal product
- •Severe hepatocellular insufficiency
- •Severe respiratory insufficiency
- •Acute exacerbation of asthma
- •Pregnancy or breast feeding
- •Necessity of general anaesthesia
- •Known alcohol, narcotics, or drug abuse
- •No consent to recording and processing of pseudonymised data according to legal requirements
- •Participation in another clinical trial within the last 30 days
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