JPRN-UMIN000023052已完成3 期
Phase three clinical trial of NPC-02 in children with hypozincemia - Phase three clinical trial of NPC-02 in children with hypozincemia
Division of Gastroenterology Department of Medical Subspecialties National Center for Child Health and Development0 个研究点目标入组 12 人开始时间: 2016年7月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 1years-old 至 18years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patient who is judged by investigator to have malabsorption (short gut syndrome, post-intestinal resection, deletion of ZIP4 gene, etc.) 2. Patient whose serum albumin is no more than 80% of institutional range 3. Patient who receives parenteral nutrition at the time or within 8 weeks of registration 4. Patient who may require parenteral nutrition or fasting during clinical trial (registration-last visit or termination of trial) 5. Patient who has taken prohibited zinc containing medicine or supplement within 12 weeks before registration 6. Patient applying zinc containing dermatological preparations 7. Patient whose renal function is impaired (estimated glomerular infiltration rate < 60 mL/min/1.73m2) 8. Patient whose hepatobiliary enzymes (AST, ALT, GGTP) or amylase is more than twice the institutional normal range 9. Patient with known allergy or hypersensitivity to zinc containing medical products (including supplement) 10. Patient with malignant tumor 11. Patient with severe heart disease, hematological disorder, etc. 12. Woman after menarche who are pregnant, suspicious of pregnant, wishing to get pregnant, or lactating 13. Patient who participated in other clinical trials within 12 weeks before registration 14. Patient who are judged unsuitable for this clinical trial by the conducting physician
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