An Open Label, Multi-center Study to Evaluate Sensory Attributes of an Antihistamine Product
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 468
- 试验地点
- 1
- 主要终点
- Proportion of Participants With Agreement of Perception of Cooling Sensation
研究概览
简要总结
In this study, researchers were primarily interested in evaluating the level of agreement of cooling sensation provided by this chewable, flavored, allergy medicine. Participants joining this study received one test drug tablet and were asked to chew completely before swallowing the drug. A questionnaire was used to collect the feedback from participants. The study involved only one (1) visit and participant stayed in this study for about 60-75 minutes to evaluate the cooling sensation as well as other sensory attributes perceived in the mouth, nose and throat.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Participants were blinded to product brand
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male adults aged 18 to 65 years of age inclusive
- •Were in good general health
- •Previous self-reported sufferers of upper respiratory allergies who at the time of the study are either asymptomatic, symptomatic but not treating and agree to use study medication or symptomatic and treating with an allergy medicine that is not an antihistamine
- •Agreed to not use antihistamine products 24 hours before and after the treatment
- •Willing to avoid eating food or candy (other than crackers consumed during testing), drinking any liquid other than water, gum chewing and teeth brushing one hour prior to testing
排除标准
- •Individuals who had used oral/systemic medications 24 hours before the first administration of test product
- •Individuals who used medications which might influence taste perception
- •Individuals who had received or used an investigational new drug in the last 30 days or had been an active participant in another clinical or market research study in the last 30 days
- •Women who were pregnant or thinking of becoming pregnant or were nursing
- •Participants with congestion at the time of study visit
- •Any self-reported symptoms or conditions that might interfere with the participants ability to complete the evaluation of the product on testing day
- •Any current medical condition that in the opinion of the Investigator or designee might interfere with normal taste and/or temperature perception (e.g., active common cold, sinus infection, bronchial infection, adenoids, paresthesia etc.)
- •History of alcohol or drug abuse
- •History of hypersensitivity or allergic reactions to any ingredients in the test product
- •Individuals with a history of glaucoma, liver or kidney disease, respiratory conditions such as chronic bronchitis or swallowing difficulties
- •Individuals who were currently wearing any kind of dental braces or with dental work or had cavities and associated pain that might affect their ability to chew a tablet
研究组 & 干预措施
Loratadine chewable tablet
Participants received one dose of loratadine chewable tablet to chew completely before swallowing.
干预措施: Loratadine (Claritin, BAY76-2211) (Drug)
结局指标
主要结局
Proportion of Participants With Agreement of Perception of Cooling Sensation
时间窗: Up to 5 minutes post ingestion of study medication
Participants were asked to response to question "the product provides a cooling sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation.
次要结局
- Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location(Up to 5 minutes post ingestion of study medication)
- Proportion of Participants With Agreement of Perception of Refreshing Sensation(Up to 5 minutes post ingestion of study medication)
- Proportion of Participants With Agreement of the Refreshing of the Cooling Sensation(Up to 5 minutes post ingestion of study medication)
- Proportion of Participants With Agreement of the Unique Sensory Experience for an Allergy Medicine(Up to 5 minutes post ingestion of study medication)
- Proportion of Participants With Agreement of Soothing Feeling on the Throat(Up to 5 minutes post ingestion of study medication)
- Time to Perception of Cooling Sensation(Up to 60 minutes post ingestion of study medication)
- Proportion of Participants With Agreement of Liking the Flavor Sensation of the Product(Up to 5 minutes post ingestion of study medication)
- Proportion of Participants With Agreement of the Great Taste of the Product(Up to 5 minutes post ingestion of study medication)
- Duration of Cooling Sensation(Up to 60 minutes post ingestion of study medication)
- Proportion of Participants With Agreement of the Enjoyable Product Experience(Up to 5 minutes post ingestion of study medication)