EUCTR2005-003588-22-GB进行中（未招募）1 期
A single centre, randomised, single (patient) blind, single dose, parallel group exploratory study to compare the efficacy of an 8.75mg flurbiprofen lozenge (Strefen) with a 3mg benzydamine lozenge (Difflam) following oral administration in 200 subjects with sore throat. - Comparator study of Strefen and Difflam
Boots Healthcare International Limited0 个研究点目标入组 200 人开始时间: 2005年10月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
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 subjects to whom all of the following conditions apply will be included:
- •1) Age 18 to 65 years
- •2) Sex: Male and female subjects are eligible for entry.
- •3) Primary diagnosis: Sore throat of <7 days duration, rated as moderate to severe on a subjective rating scale.
- •4) Status: subjects will be members of the public who respond to advertising about the study.
- •5) Subjects who have given written informed consent.
- •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
- •Subjects to whom any of the following conditions apply must be excluded:
- •1) Hypersensitivity to any of the constituents, aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS).
- •2) Subjects with existing, or history of peptic ulceration.
- •3) Subjects with a history of bronchospasm, rhinitis or urticaria associated with aspirin or other NSAIDS.
- •4) Subjects with existing, or history of bronchial asthma.
- •5) Subjects with hereditary fructose intolerance, glucose-galactose malabsorption syndrome or saccharose-isomaltose insufficiency.
- •6) Subjects with renal, cardiac or hepatic impairment.
- •7) Subjects with a potential for abnormal bleeding
- •8) Subjects with hypertension.
- •9) Use of a pastille, lozenge, spray or other topical throat treatment within 2 hrs of study entry, any sore throat medication containing a local anaesthetic within 4 hrs of study entry, a short-acting analgesic within 6 hrs of study entry, or any long acting or slow release analgesic within 24 hrs of study entry.
- •10) Women of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions.
- •11) Those previously randomised into the study.
- •12) Subjects holding North American citizenship as the BHI Clinial Trials Insurance does not cover those persons.
- •13) Those who have participated in a clinical trial in the previous two months.
- •14) Those unable in the opinion of the investigator to comply fully with the study requirements.
研究者
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