NCT02184325已完成2 期
Safety and Tolerability of Kiddi® Pharmaton Fizz Effervescent Tablets, Comparing the Marketed Formula With an Improved One With a Reduced Mineral Amount, and a Comparator Product: a Double-blind, Controlled, Randomised, Three Arm Cross-over Study in Children
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 主要终点
- Incidence of total drug-related adverse events
研究概览
简要总结
Study to evaluate the tolerability and safety of Kiddi® Pharmaton Fizz effervescent tablets, in children of 6 to 14 years, comparing a given formula with an improved one with reduced mineral content (qualitatively equivalent to the first one) and a comparator product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 6 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of both sexes aged between 6 and 14 years, inclusive
- •Children, healthy or during convalescence, for which prevention or treatment of marginal vitamin deficits is indicated
- •Willingness of the children and parents to give their written informed consent, according to Good Clinical Practice and local regulations
- •Pregnant children will not be excluded
排除标准
- •Has taken medications containing vitamins A or D, retinoids, or iron during the 4 weeks preceding the study enrolment
- •Pre-treatment (less than 2 weeks prior the inclusion in this trial) and/or concomitant treatment with any drug that may influence the trial symptomatology, and may interfere with the evaluation of the safety of the test drug
- •Participation in other clinical trials within the last 4 weeks and concurrent participation in another clinical trial
- •Relevant allergy or kown hypersensitivity to one of the ingredients of the investigational drug
- •Has any serious disorder that may interfere with the participation to the trial
- •Malabsorption syndrome, liver and/or renal diseases or juvenile diabetes
- •Increased calcium blood concentration, or an increased calcium-excretion
- •Evident states of protein deficiency
- •Presence of lysinemia (defect of the enzyme lysine ketoglutarate reductase)
研究组 & 干预措施
Kiddi® Pharmaton Fizz, effervescent tablets
Experimental
with reduced amount of minerals
干预措施: Kiddi® Pharmaton Fizz, effervescent tablets (Drug)
Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula
Active Comparator
干预措施: Kiddi® Pharmaton Fizz, effervescent tablets (Drug)
Comparator product
Active Comparator
in the form of a product that is a market leader
干预措施: Comparator product (Drug)
结局指标
主要结局
Incidence of total drug-related adverse events
时间窗: up to 19 days
次要结局
- Incidence of all individual drug-related adverse events(up to 19 days)
- Assessment of overall tolerability and acceptance on a 4-point verbal rating scale(up to day 19)
研究者
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