EUCTR2015-005240-33-GB进行中（未招募）1 期
A single centre, randomised, single-blind, parallel group single dose study to compare the speed of onset of ibuprofen gel, ibuprofen gel with levomenthol, and diclofenac gel in the relief of pain from strains, sprains and sports injuries. - Ascension Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 182
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
入选标准
- •Only patients to whom all of the following conditions apply will be included:
- •1)Patients who have given written informed consent.
- •2)Age: =16 to =75.
- •3)Both male and female patients may be included.
- •4)Primary diagnosis: Patients with an acute soft tissue injury. Patients who have at least moderate pain - = 6 on the pain numerical rating scale (NRS) at baseline.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Patients to whom any of the following conditions apply must be excluded:
- •1)Inflammed or broken skin in area of application
- •2)Those patients known to be hypersensitive to ibuprofen, levomenthol, or any
- •of the ingredients or sensitive to aspirin, or other NSAIDS including when
- •taken by mouth, or asthmatic patients in whom aspirin or non-steroidal antiinflammatories are known to precipitate asthmatic attacks, rhinitis or urticaria..
- •3)Any injury considered to be chronic in the view of the Investigator.
- •4)active peptic ulcer
- •5)known significant renal disease
- •6)pregnant or lactating women
- •7)Those who have used any analgesic, within the previous 8 hours.
- •8)Those who have used a longer acting or slow release analgesic during the previous 24 hours e.g. Piroxicam and Naproxen.
- •9)Those with a history of severe hepatic impairment
- •10)Those with a history (within 2 years) of alcohol abuse..).
- •11)Those unable to refrain from smoking during their stay in the investigative site.
- •12)Women of childbearing potential, who report they are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions,
- •13)Those previously randomised into the study.
- •14)Those who have participated in a clinical trial in the previous 30 days. Thirty days are calculated from time of last dosing in the prior trial to time of anticipated dosing in this trial.
- •15)Those unable in the opinion of the investigator to comply fully with the study requirements, e.g. such as those who cannot comprehend or correctly use the pain rating scales.
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