跳至主要内容
临床试验/ISRCTN38904316
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

发起方
Applied Pharma Research (Switzerland)

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