NCT02321865已完成3 期
Dose Adjustment 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 43 人开始时间: 2015年1月21日最近更新:
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
- 43
- 试验地点
- 1
- 主要终点
- The ratio of the patients who could maintain target serum zinc concentration
研究概览
简要总结
The objective of this study is to check the dose control method of NPC-02 and the holding effect for the target serum zinc concentration in patients with zinc deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The serum zinc concentrations are under the nomal level before registration
- •Able to taking a tablet
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
干预措施: NPC-02 (Drug)
结局指标
主要结局
The ratio of the patients who could maintain target serum zinc concentration
时间窗: approx. 12-24 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Randomized, Double-Blind, Placebo Controlled Study of NPC-02 in Patients With Zinc DeficiencyZinc DeficiencyNCT02337569Nobelpharma57
终止
2 期
ZP120 Add-on to Furosemide in Treatment of Acute or Sub-Acute Decompensated Heart FailureHeart Failure, CongestiveNCT00283361Zealand Pharma130
进行中（未招募）
2 期
A Herbal Compound for EczemaEczemaInflammationAtopic DermatitisNCT06758752Fasa University of Medical Sciences110
已完成
1 期
Safety and PK of Nikkomycin Z in Healthy SubjectsHealthyNCT00834184University of Arizona32
已完成
4 期
Ziconotide as First-Line IDTNeuropathic PainNCT03321955Albany Medical College13