NCT04104815撤回不适用
A Study to Evaluate the GI Tolerance and Acceptability of a New Thickener for Dysphagia Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- HCP Product Satisfaction Questionnaire
研究概览
简要总结
The current study is designed to evaluate the gastrointestinal tolerance and acceptability of a new thickener for dysphagia patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has voluntarily signed and dated an ICF approved by an IRB/IEC, and provided applicable privacy authorization prior to any participation in the study.
- •Subject is diagnosed with dysphagia.
- •Subject is under the care of a Speech and Language Therapist and is currently using a thickener.
- •Subject currently has normal GI function.
- •Subject is interested in participating in the study, willing to comply with the study protocol and product.
- •Subject who is able to consent and is able to evaluate the product.
排除标准
- •Subject has a normal swallow.
- •Subject at high risk of aspiration with oral fluids requiring nil by mouth and enteral tube feeding.
- •Subject has impaired renal function.
- •Subject has liver failure, decompensated chronic liver disease, active hepatitis B or C receiving treatment, or hepatic encephalopathy.
- •Subject has severe dementia or unable to communicate or consent or delirium, eating disorder, history of significant neurological or psychiatric disorder affecting abilities to answer questions, alcoholism, substance abuse or other conditions that may interfere with study product consumption or compliance with study protocol procedures.
- •Participant is known to be allergic or intolerant to any ingredient found in the study product.
- •Participation in another study that has not been approved as a concomitant study.
- •Subject has a clinical condition that is contraindicated with this product such as hepatic and renal disease.
- •Subject has a clinical condition which may interfere with gastrointestinal tolerance.
- •Subject is pregnant.
结局指标
主要结局
HCP Product Satisfaction Questionnaire
时间窗: Study Day 7
5 Questions; 3 of the questions utilize a 5 point scale in the positive direction; 2 of the questions are closed categories yes or no.
Product Compliance
时间窗: Study Day 1 to Study Day 7
Patient thickened fluids consumption records
Bristol Stool Scale
时间窗: Study Day 1 to Study Day 7
The Bristol Stool Scale is used to describe the consistency of stools. Numbers 1-7 are assigned to stools based on descriptions on the scale from hard to liquid.
Palatability of Study Product
时间窗: Study Day 1 and Study Day 7
A 5 point scale in the positive direction
次要结局
未报告次要终点
研究者
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