ISRCTN38904316暂停未知
PKU GOLIKE PLUS 16+ – acceptability and tolerance market research study
Applied Pharma Research (Switzerland)0 个研究点目标入组 15 人开始时间: 2019年7月10日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 暂停
- 发起方
- 入组人数
- 15
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
- 性别
- All
入选标准
- •1. Male and female patients with a diagnosis of phenylketonuria, aged =16 years
- •2. Subjects who are already taking a protein substitute for PKU and are willing to replace at least part of their prescription with the new study product for 7 days
- •3. Willing and able to give a written informed consent
排除标准
- •1. Presence of serious concurrent illness
- •2. Presence of current illnesses that could interfere with the study (for instance, inflammatory status, etc)
- •3. Status of pregnancy or lactation, for females
- •4. Likelihood that the patient will not be compliant with the protocol requirements, in the judgement of the Lead Dietitian
- •5. Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study
- •6. Use of antibiotics in the week prior to study entry
- •7. Use of sapropterin
- •8. Patients aged less than 16 years
研究者
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