CTRI/2017/03/008052已完成3 期
A Prospective, Open-label, Multicenter, Phase 3 Study to Assess the Acceptability of and Adherence to a 10-Day Regimen of Zinc Sulphate Dispersible Tablets for Treatment of Acute Childhood Diarrhea.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 5
- 主要终点
- To assess the acceptability in terms of adherence of zinc sulphate dispersible tablets.
研究概览
简要总结
This study is A Prospective, Open-label, Multicenter, Phase 3 Study to assess the acceptability of and adherence to a 10-Day regimen of Zinc Sulphate dispersible tablets for treatment of Acute Childhood Diarrhea in 310 patients.
The study is to be conducted in four centers in India and eight in Malaysia.
The primary outcome measures will assess the acceptability of and adherence to a 10-Day Regimen of Zinc Sulphate Dispersible Tablets.
The secondary outcomes will be to assess the safety and acceptability in terms of palatability of zinc sulphate dispersible tablets in children aged between 3 and 59 months with acute diarrhea and to compare the efficacy of zinc sulphate dispersible tablets in children aged between 3 to ≤18 months and >18 to 59 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 3.00 Month(s) 至 59.00 Month(s)（—）
- 性别
- All
入选标准
- •Subject with acute diarrhea (3 or more loose, liquid, or watery stools in past 24 hours).
- •Subject must be healthy except for study-related disease condition in the opinion of the Investigator.
- •Subject’s parent/guardian should be ready to comply with the study procedures and adhere to the prohibitions and restrictions specified in the protocol.
- •Subject’s parent/guardian willing to sign an ICF indicating that they have understood the purpose of and procedures required for the study, and are willing for their child’s participation in the study.
排除标准
- •Subject with pedal edema or who is severely dehydrated e.g. abnormally sleepy or lethargic, sunken eyes, drinking poorly or not at all, tachycardia, tachypnea, markedly reduced skin turgor; and require hospitalization.
- •Subject with co-morbidity associated with excessive vomiting, e.g., whooping cough, pylorospasm, congenital pyloric stenosis, hiatus hernia, other obstructive defects of the gastrointestinal tract or a history of cow’s milk allergy, etc.
- •Subject with any other known systemic complication, e.g. pneumonia, meningitis, sepsis, paralytic ileus, severe malnutrition, hypoglycemia, serum electrolyte disorders, seizure that require admission to the hospital.
- •Subject with chronic or persistent diarrhea and dysentery, had developmental delay (>1 year behind milestones), or having a birth defect or having a medical condition that could interfere with the ability to discriminate taste, e.g., common cold or a sinus or bronchial infection.
- •Subject already on zinc supplementation, zinc fortified infant formulae, or receiving drugs that may inhibit zinc absorption such as iron supplements, penicillamine, sodium valproate, and ethambutol.
- •Subject who has taken prescription drugs other than those prescribed for diarrhea during the preceding 24 hours.
- •Subject with hypersensitivity to zinc or has known food or drug allergies to any of the constituents of the study drug product.
- •Subject who has participated in any other clinical study within past 30 days or has participated in a similar study for zinc sulphate earlier.
结局指标
主要结局
To assess the acceptability in terms of adherence of zinc sulphate dispersible tablets.
时间窗: 10 Days
次要结局
- To assess the acceptability in terms of palatability of zinc sulphate dispersible tablets in children aged between 3 and 59 months with acute diarrhea.(To compare the efficacy of zinc sulphate dispersible tablets in children aged between 3 to ≤18 months and 18 to 59 months.)
研究者
研究点 (5)
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