NCT02337569已完成3 期
A Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc Deficiency
Nobelpharma1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- The change amount of serum zinc concentration between starting and 8 weeks after dosing
研究概览
简要总结
The objective of this study is to evaluate efficacy and safety of NPC-02 in patients with Zinc Deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The serum zinc concentrations are under the normal level before registration
排除标准
- •Heavy hepatitis
- •Malignant tumor
- •Severe heart disease, hematological disorder, kidney disease and pancreatic disease, etc.
- •The serum albumin under 2.8 g/dL
- •Patient of allergy and hyperesthesia to zinc containing medicine manufacturing (including supplement)
- •Patient who was taking a medicine including the zinc (including supplement) within 12 weeks before registration
- •Pregnant, suspected pregnant, lactating, patients who wish to have a child
- •Patient who participated in other clinical trials within 12 weeks before registration
- •Unsuitable as a target of this clinical trial judged by doctor
研究组 & 干预措施
NPC-02
Experimental
Oral dose
干预措施: NPC-02 (Drug)
Placebo
Placebo Comparator
Oral dose
干预措施: Placebos (Drug)
结局指标
主要结局
The change amount of serum zinc concentration between starting and 8 weeks after dosing
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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