An Open Label, In-use Study to Assess the Warming Sensation, Acceptability and Local Tolerability of Paracetamol 500 mg + Pseudoephedrine 30 mg Syrup Given as a 30 ml Single Dose in Subjects Suffering From Symptoms of an Upper Respiratory Tract Infection
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup
研究概览
简要总结
This is an open label, in-use study to assess the warming sensation, acceptability and local tolerability of paracetamol 500 mg + pseudoephedrine 30 mg syrup, given as a single dose in subjects suffering from symptoms of an upper respiratory tract infection. The purpose is to evaluate the acceptability concerning a warming sensation effect and its potential benefit in the target population.
The primary objective is to assess the warming sensation caused by the excipient IFF flavor 316 282, in a syrup containing paracetamol 500 mg + pseudoephedrine 30 mg per 30 ml syrup. The syrup contains (0.15% w/v) warming flavor.
The Secondary Objectives are to assess subject acceptability of the syrup and the safety and tolerability of the syrup. The study will be run in fifty-six (56) subjects suffering from symptoms of an upper respiratory tract infection (URTI) for 7 days or less, e.g. nasal congestion associated with colds and flu symptoms such as pain, headache and/or fever. Subjects must have one or more symptoms per category:
- mild to moderate body pain, headache, fever or sore throat
- nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing Adolescents will be included in the study population
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have one or more symptoms per category (see also screening assessment of cold symptoms, section 6.1):
- •mild to moderate body pain, headache, fever or sore throat
- •nasal congestion (blocked nose) with or without rhinorrhea (runny nose) or sneezing
排除标准
- •Baseline sore throat pain of severe intensity, e.g. rated as 3 on a 4-point ordinal scale (0=not present, 1= mild, 2=moderate, 3=severe)
- •Baseline dry cough of severe intensity, e.g. rated as 3 on a 4-point ordinal scale (0=not present, 1= mild, 2=moderate, 3=severe)
- •Subject has a productive cough.
- •History of hypersensitivity to any of the study drugs and the listed excipients or to drugs of similar chemical classes
- •Subjects with allergic asthma.
- •Use of any inhaler, medicated confectionary, throat lozenges, throat pastilles, sprays, any products with demulcent properties such as chewing gums and boiled sweets or mints, in the 6 hours prior to dosing.
- •Use of any medication for sore throat containing a local anaesthetic within the 6 hours prior to dosing.
- •Use of paracetamol, any NSAID or any oral nasal decongestant within 6 hours prior to dosing.
- •Use of substances of abuse or antihistamines within 24 hours of dosing.
- •Drinking of tea, coffee or other caffeinated beverages 1 hour prior to dosing.
- •Suffering from hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, heart disease or other acute or chronic medical condition that, in the opinion of the investigator, would put the subject at a higher risk or affect the conduct and/or the results of the study.
- •Use of any antidepressants, monoamine oxidase inhibitors or beta-blocking drugs in the 28 days prior to dosing
- •A history of alcohol abuse or subject admits to regular consumption of alcohol in excess of the recommended weekly limits of 21 units for females and 28 units for males.
- •Subject is a current smoker of ≥10 cigarettes per day (or reports equivalent smoking habits using other tobacco products).
- •Subject has smoked or chewed tobacco products within 12 hours of dosing.
- •History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
研究组 & 干预措施
Upper Respiratory Infections
干预措施: IFF flavor 316 282, Paracetamol, Pseudoephedrine (Drug)
结局指标
主要结局
Warming Sensation Caused by the Excipient IFF Flavor 316 282, in a Syrup Containing Paracetamol 500 mg + Pseudoephedrine 30 mg Per 30 ml Syrup
时间窗: 1 minute
Intensity of warming sensation felt by subjects between predose to 1 minute postdose where 0 = no warming sensation and 100 = strongest possible warming sensation
次要结局
- Subject Acceptability of the Syrup(1 hour)
- Safety and Tolerability of the Syrup(1 hour)