Investigation of Palatability of an Oral Dispersible Tablet (ODT) Formulation in Children Aged 2 to 10 Years
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Parent-reported palatability assessed by interview
研究概览
简要总结
This is a cross-sectional study investigating the palatability of an oral dispersible tablet with no pharmacologically active agent (carrier tablet) in children without underlying acute or chronic disease aged 2 to 10 years of age.
详细描述
Oral dispersible tablets (ODTs) are a monolithic solid formulation potentially appropriate for a wide range of paediatric age groups. They also have a number of advantages over more frequently used formulation types, such as suspensions. Currently few Commercial products are available as ODTs for administration to children. Investigators aimed to investigate the palatability of an oral dispersible tablet with no pharmacologically active agent (carrier tablet) by assessing overall parent-reported, observer-reported and, where appropriate, child-reported acceptance of the formulation. In addition, investigators assessed the in situ disintegration behaviour of the carrier tablet.
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
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 2 and 10 years
- •Attending study site as an outpatient during the study period.
- •Informed consent form for study participation signed by legal guardian
- •Verbal assent to participation from child
排除标准
- •Wearing dental braces
- •Injuries or inflammatory disease affecting the oral cavity or throat
- •Dysphagia
- •Olfactory impairment
- •Known renal impairment
- •Known hypercalcaemia,
- •Any known allergy against medications
- •Ongoing antibiotic treatment at the time of the study
- •Moderate-severe developmental delay as reported by the parents
- •Parents/legal guardians are unlikely to reliably complete structured questionnaire because of significant language barriers
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Previous enrolment into the current study
研究组 & 干预措施
Oral dispersible tablet
5 mm calcium carbonate based ODT will be administered by placing it in the buccal pouch (children aged 2-5 years) or on the tongue (children aged 6-10 years).
干预措施: Oral dispersible tablet (Other)
结局指标
主要结局
Parent-reported palatability assessed by interview
时间窗: Day 1
5-point Likert scale, 1 "completely acceptable" to 5 "completely unacceptable"
Child-reported palatability (children aged 6-10 years only) assessed by interview
时间窗: Day 1
6-point Facial Hedonic Scale (0 "no discomfort on taking tablet" to 10 "maximum discomfort on taking tablet"
次要结局
- Observer-reported palatability assessed by questionnaire(Day 1)
- In-situ disintegration behaviour of carrier tablet(Day 1)