Randomized, Single Blind, Cross-over Study to Evaluate the Palatability of New Orally Disintegrating Tablets of PZQ and L-PZQ Versus Current PZQ Tablets in African Children Age 6-11 Years
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP])
研究概览
简要总结
The primary objective of the trial is to compare the "overall palatability" of the new orally disintegrating L-Praziquantel (L-PZQ ODT), the new racemate PZQ ODT (Rac-PZQ ODT) and the current available racemate PZQ tablets (reference) as assessed by means of human gustatory sensation tests (100 millimeter [mm] visual analogue scale [VAS] scoring modified by the incorporation of a 5 point facial hedonic scale).
The secondary objectives are
- To obtain feedback from children regarding the taste of different formulations using an open ended questionnaire
- To document any discomfort or other observation in relation to acceptance of the study medication
详细描述
Initially pupils will be invited with their parents to school where they will be asked to give consent/assent in to the study and they will be instructed on how to follow up the taste study procedures. Enrollments will occur in the health facilities in Ikwiriri/Kibiti at the end of successive training. Informed consent from parents and guardians and assent from the child will be obtained before participation in the study. The study will be conducted in school children 6 years and older as recommended by the Committee for medical product for human use (CHMP) reflection paper: formulations of choice for the pediatric population.
-This is a randomized, five-period cross over, single center swill and spit taste study where the drug will not be swallowed but will be spit out after tasting.
On Day 1, the subjects will assess the palatability of the following arms in a randomized sequence:
- L-PZQ ODT (150 mg) put and disintegrated in the mouth
- Rac- PZQ ODT (150 mg) put and disintegrated in the mouth
On Day 2, the subjects will assess the palatability of the following arms in a randomized sequence:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Period 1 and 2
A-B or B-A where A: L-PZQ ODT (MSC 2499550A) put on tongue; B: Rac-PZQ ODT (MSC1028703A) put on the tongue
干预措施: L-PZQ ODT (Drug)
Period 1 and 2
A-B or B-A where A: L-PZQ ODT (MSC 2499550A) put on tongue; B: Rac-PZQ ODT (MSC1028703A) put on the tongue
干预措施: Rac-PZQ ODT (Drug)
Period 3, 4 and 5
C-D-E; C-E-D; D-E-C; D-C-E; E-C-D; E-D-C where C: L-PZQ ODT (MSC 2499550A) dispersed in water; D: Rac-PZQ ODT (MSC1028703A) dispersed in water; E: Cesol® 150 mg crushed in water
干预措施: L-PZQ ODT (Drug)
Period 3, 4 and 5
C-D-E; C-E-D; D-E-C; D-C-E; E-C-D; E-D-C where C: L-PZQ ODT (MSC 2499550A) dispersed in water; D: Rac-PZQ ODT (MSC1028703A) dispersed in water; E: Cesol® 150 mg crushed in water
干预措施: Rac-PZQ ODT (Drug)
Period 3, 4 and 5
C-D-E; C-E-D; D-E-C; D-C-E; E-C-D; E-D-C where C: L-PZQ ODT (MSC 2499550A) dispersed in water; D: Rac-PZQ ODT (MSC1028703A) dispersed in water; E: Cesol® 150 mg crushed in water
干预措施: Cesol® (Drug)
结局指标
主要结局
Overall Palatability Visual Analogue Scale (VAS) Score at 0 Minute (Right After the Spit-out of the Investigational Medicinal Product [IMP])
时间窗: 0 minute (Right After the Spit-out of the IMP)
Overall palatability was assessed on a 0 to 100 unit VAS scale, where higher scores indicate better palatability.
次要结局
- Overall Palatability VAS Score at 2-5 Minutes(2-5 minutes (After the IMP has been spat out))
- Number of Subjects With Mouth Feeling and Taste Description Evaluation(2-5 minutes (After the IMP has been spat out))
- Number of Subjects With Discomfort or Observations Relating to Acceptance of the Study Medication(2-5 minutes)