EUCTR2006-006942-33-CZ进行中（未招募）不适用
Randomised, Double Dummy, Placebo Controlled, Multicentre, Parallel-Group, Single Dose Study to Compare the Analgesic Efficacy and Safety of IBALGIN Extra Fast /ibuprofen lysin/ to conventional Ibuprofen in the Treatment of Acute Pain
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Zentiva a.s.
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
- •Written informed consent obtained
- •Subject is indicated for outpatient surgical removal of one or more third molars, at least one of which is impacted in bone
- •Subjects between 18 – 60 years, both sexes
- •Negative pregnancy test in females with childbearing potential
- •Subject agrees not to take analgesics other than protocol defined rescue analgesics during treatment, anti-inflammatory drugs, sedative-hypnotics, or antidepressants, tranquilizers, alcohol or caffeine-containing beverages up to 6 hrs post dose
- •Ability to read, comprehend, and record information required by protocol.
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Acute purulent infammation in the area of the planned bony-impacted 3rd molar removal
- •Another acute or chronic painful physical condition
- •Use of any analgesics, anti-inflammatory drugs, sedative-hypnotics, or antidepressants, tranquilizers, alcohol or caffeine-containing beverages from midnigt of the night prior to surgery
- •Subject has a history or presence of significant organ disease
- •Active gastric or duodenal ulcer
- •Clotting and a haematogenesis disorders
- •Any other disease or condition which may interfere with study assessments as judged by the investigator
- •Subjects taking part in any other clinical trial or having participated in a clinical trial within the previous 3 months
- •Subjects with history of hypersensitivity to the study drug or its excipients
- •Subjects likely not to comply with the study procedures or with difficulties to understand the study procedures as judged by the investigator
- •Pregnancy or breast-feeding
研究者
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