试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Successful Swallowing of the Mock-RP
研究概览
简要总结
A prospective, single-center, open-label, single-arm, observational study assessing participant experience with swallowing the Mock-RP
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant age is 21 - 75 years
- •Participant understands the nature of the study, is willing to comply with protocol defined evaluations, and provide written informed consent
- •Participant currently taking injections to treat a chronic disorder
- •Non-pregnant, non-lactating female NOTE: Females who are of childbearing potential must have had a negative pregnancy test on day of screening
排除标准
- •Active case of COVID-19
- •History of Dysphagia
- •History of dementia (e.g., Alzheimer's, vascular dementia, dementia with Lewy bodies, etc.)
- •Participant self-reports issues with swallowing pills.
- •History of drug or alcohol abuse or any other factor that, in the Investigator's opinion, may interfere with the participant's ability to cooperate and comply with the study procedures
- •History of allergic reaction to a component of the Mock-RP
- •History which, in the investigator's judgement, makes the participant ineligible or exposes the participant to unacceptable risks
结局指标
主要结局
Successful Swallowing of the Mock-RP
时间窗: Immediately after swallowing
Percent of participants successfully swallowing the Mock-RP as reported on the questionnaire.
Mock-RP Swallowing Experience
时间窗: Immediately after swallowing
Participant experience with swallowing Mock-RP stratified by number of years using injections.
Percent of Participants Who Would Chose a Pill Instead of Injection
时间窗: Immediately after swallowing
Assess if a participant would choose a pill instead of their current injection therapy if a pill becomes available.
Adverse Events
时间窗: Immediately after swallowing
All adverse events categorized by type and frequency.
次要结局
未报告次要终点