EUCTR2006-006769-17-GB进行中（未招募）不适用
A randomised, controlled, open-label, single-centre, parallel group,pilot study to investigate the onset of action of a lozenge comparedwith a caplet in patients with sore throat. - Strepsils onset of action study
Reckitt Benckiser Healthcare International Ltd0 个研究点目标入组 60 人开始时间: 2007年2月26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
- 入组人数
- 60
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
- •1)Age: Patients aged 16 to 65 years of age are eligible to participate.
- •2)Sex: Both males and females are eligible for entry
- •3)Primary diagnosis: All patients selected for this study will have a sore throat due to upper respiratory tract infection. In addition they will have a TPA score of = 5 (range 0 – 21), a throat soreness scale of = 6 on the 11-point ordinal scale and a difficulty in swallowing score of = 60 mm on the 100 mm VAS.
- •4)Patients who have given written informed consent.
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1)A history of allergy (including angioedema, urticaria, bronchospasm and rhinitis) related to treatment with ibuprofen, flurbiprofen, aspirin or other NSAIDs or to formulation constituents, eg
- •2)A history of peptic ulcers, duodenal ulcers, or gastrointestinal bleeding.
- •3)A history of frequent dyspepsia, heartburn, or indigestion.
- •4)Inflammatory bowel disease e.g. Crohn’s or ulcerative colitis, chronic/acute hepatic renal or coagulation disorders that might preclude NSAID use.
- •5)Severe coughing
- •6)Those who have used any analgesic, antipyretic or cold” medication (e.g. decongestant, antihistamine, antitussive, or throat lozenge) within the previous 8 hours.
- •7)Those who have taken any medicated confectionary or products with demulcent properties such as sweets, within the previous 2 hours.
- •8)Those with any painful condition that may distract attention from sore throat pain e.g. mouth ulcers, etc.
- •9)Those unable to refrain from smoking during their stay in the research centre.
- •10)Woman of childbearing potential, who are pregnant or lactating, seeking pregnancy or failing to take adequate contraceptive precautions, (i.e. an oral contraceptive, an approved hormonal implant, an intrauterine device or condoms/diaphragm and spermicide). A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone an hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral ovariectomy (oophorectomy).
- •11)Those previously randomised into this study.
- •12)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.
- •13)Those unable, in the opinion of the investigator, to comply fully with the study requirements.
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