Double-blind Study in Paediatric Epileptic Subjects Aged From 5 to Less Than 8 Years to Compare the Subject Preference for ESL Suspension Formulation With Alternative Flavours
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 3
- 主要终点
- Assessment of Taste Preference
研究概览
简要总结
The purpose of this study is to investigate the taste preference in children of 3 different flavours of the ESL oral suspension.
详细描述
Children between the age of 5 and <8 years who are patients of the participating investigators will be screened for participation in the study. This may be at a regularly planned visit or the investigators may invite children who would be suitable candidates. Children who agree to participate will be invited to come back to the clinic on a single Study Day and will be randomised to a particular sequence of flavours. On the Study Day, all children will be given 3 different flavoured samples of Eslicarbazepine acetate (ESL) oral suspension for tasting, in the sequence to which they were randomised, in a double-blind, standardized setting. Each sample will consist of 2.5 mL and is to be given with a spoon in a double-blind manner, and is not to be swallowed. After tasting and spitting out each sample the child will be asked to rate the taste on a 10 cm visual analogue scale incorporating a facial hedonic scale. At the end of the session, the child will also be asked which flavour they thought tasted the best and which tasted the worst, to assess overall taste. A follow-up telephone contact interview will be performed between 1 and 4 days after the Study Day to collect adverse event (AE) data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A written informed consent form signed by the subject's parent(s) or guardian(s) and an assent form for any 7-year-old subjects signed by subjects.
- •Male or female, between the age of 5 to <8 years.
- •Diagnosed with partial-onset epilepsy.
- •Is considered, in the opinion of the investigator, to be able to make the required taste assessment.
排除标准
- •Uncontrolled cardiac, renal, hepatic, endocrine, gastrointestinal, metabolic, haematological, or oncology disorder.
- •Known hypersensitivity to carboxamide derivatives or tricyclic antidepressants.
- •Strong congestion, flu, or any other acute illness that could influence the child's sense of taste.
- •A known swallowing or taste perception problem.
- •Currently or previously treated with ESL.
- •Concomitant participation in another drug clinical trial.
- •Any other condition or circumstance that, in the opinion of the investigator, could compromise the subject's ability to comply with the study protocol.
研究组 & 干预措施
ESL Banana taste
Subjects were to be enrolled until there were at least 30 evaluable subjects (of whom at least 60% were <7 years of age). Evaluable subjects were those who completed 3 Visual analogue scale (VAS), 1 for each of the 3 tasting steps with the 3 flavoured oral suspensions.
干预措施: ESL Banana taste (Drug)
ESL Grape taste
Subjects were to be enrolled until there were at least 30 evaluable subjects (of whom at least 60% were <7 years of age). Evaluable subjects were those who completed 3 Visual analogue scale (VAS), 1 for each of the 3 tasting steps with the 3 flavoured oral suspensions.
干预措施: ESL Grape taste (Drug)
ESL Tutti-Frutti taste
Subjects were to be enrolled until there were at least 30 evaluable subjects (of whom at least 60% were <7 years of age). Evaluable subjects were those who completed 3 Visual analogue scale (VAS), 1 for each of the 3 tasting steps with the 3 flavoured oral suspensions.
干预措施: ESL Tutti-Frutti taste (Drug)
结局指标
主要结局
Assessment of Taste Preference
时间窗: single Study Day
Subject preference for 3 flavours of the ESL oral suspension was assessed based on a measured score using a 0-10 cm (minimum and maximum measured values) Visual Analogue Scale (VAS). Higher values represent the stronger preference.
次要结局
未报告次要终点