A Multi-center, Pediatric, Open-label, Preference Study of Desloratadine 2.5 mg Reditab (SCH34117) and Zyrtec 5.0 mg Chewable Tablet Medications
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 217
- 主要终点
- Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.
研究概览
简要总结
This was a randomized, open-label, 2-way cross-over study, comparing desloratadine RediTab 2.5 mg to a marketed chewable antihistamine oral medication (Zyrtec® 5 mg
Chewable Tablet). Subject preference for one product or the other was determined. Acceptability of product attributes (Taste and Feeling in the Mouth) was rated using a "smile" face scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject, and the parent/guardian of the subject, was to have demonstrated their willingness to participate in the study and comply with its procedures by signing a written Informed Consent.
- •Subject was to be 6-11 years of age, of either sex and of any race.
- •If female, subject was to be premenarcheal.
- •Subject was to be willing to avoid eating, drinking, gum chewing, and teeth brushing for one hour prior to enrollment.
- •Subject was to be free of any clinically significant disease that would interfere with study evaluations, including allergic rhinitis and respiratory infections.
- •Subject was to have understood and been able to adhere to the dosing and visit schedules.
排除标准
- •If female, subject who was pregnant, intended to become pregnant during the study or nursing.
- •Subject had used any investigational product within 30 days prior to enrollment.
- •Subject had any of the following clinical conditions: history of any significant medical conditions (based on reporting by parent or guardian): e.g., diabetes, heart disease, liver disease, kidney disease, breathing problems, cough with excessive phlegm, or persistent or chronic cough.
- •Subject had a current medical condition that, in the opinion of the Investigator or designee, may interfere with the ability to discriminate taste (e.g., common cold, sinus infection, bronchial infection, allergic rhinitis, etc.).
- •Subject was participating in any other clinical study(ies).
- •Subject was part of the staff or a family member of the staff personnel directly involved with this study.
- •Subject was allergic to or has sensitivity to the study drug or its excipients.
- •Subject had a history of allergic reaction to prescription and/or OTC medications and/or food products.
- •Subject had used any antihistamines within 24 hours prior to tasting as outlined in Section 9.4.
- •Subject used sedatives, tranquilizers, or monoamine oxidase inhibitor drugs.
研究组 & 干预措施
RediTab/Zyrtec
Subjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference.
干预措施: Desloratadine (Drug)
RediTab/Zyrtec
Subjects received a single dose of desloratadine RediTab followed 8-10 minutes later by a single dose of Zyrtec chewable tablet followed thereafter by a statement of preference.
干预措施: Zyrtec® (cetirizine) (Drug)
Zyrtec/RediTab
Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab followed thereafter by a statement of preference.
干预措施: Desloratadine (Drug)
Zyrtec/RediTab
Subjects received a single dose of Zyrtec chewable tablet followed 8-10 minutes later by a single dose of desloratadine RediTab followed thereafter by a statement of preference.
干预措施: Zyrtec® (cetirizine) (Drug)
结局指标
主要结局
Number of Subjects Who Preferred Desloratadine RediTab or Zyrtec Chewable Tablet.
时间窗: Following the second dose (8-10 minutes after the first dose)
A product preference questionnaire was completed after the administration of the second study drug. An interviewer instructed the subject "now that you have tasted the two tablets, show us which tablet you like more" and the subject then marked which tablet he/she preferred. If the subject had no preference, the response was recorded accordingly.
次要结局
未报告次要终点