Pill Swallow Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2021-08-27

Brief Summary

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A prospective, single-center, open-label, single-arm, observational study assessing participant experience with swallowing the Mock-RP

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Detailed Description

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Conditions

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Not Determined

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Swallow Group

Group Type OTHER

Mock-RP

Intervention Type OTHER

Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.

Interventions

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Mock-RP

Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Participant age is 21 - 75 years
2. Participant understands the nature of the study, is willing to comply with protocol defined evaluations, and provide written informed consent
3. Participant currently taking injections to treat a chronic disorder
4. Non-pregnant, non-lactating female NOTE: Females who are of childbearing potential must have had a negative pregnancy test on day of screening

Exclusion Criteria

1. Active case of COVID-19
2. History of Dysphagia
3. History of dementia (e.g., Alzheimer's, vascular dementia, dementia with Lewy bodies, etc.)
4. Participant self-reports issues with swallowing pills.
5. 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
6. History of allergic reaction to a component of the Mock-RP
7. History which, in the investigator's judgement, makes the participant ineligible or exposes the participant to unacceptable risks

Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No