CompletedNot Applicable

Pill Swallow Study

United States150 participantsStarted 2021-06-01

Plain-language summary

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

Who can participate

Age range21 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Successful Swallowing of the Mock-RP

Timeframe: Immediately after swallowing

Percent of Participants Who Would Chose a Pill Instead of Injection

Timeframe: Immediately after swallowing

Mock-RP Swallowing Experience

Timeframe: Immediately after swallowing

Mock-RP Swallowing Experience

Timeframe: Immediately after swallowing

Mock-RP Swallowing Experience

Timeframe: Immediately after swallowing

Adverse Events

Timeframe: Immediately after swallowing

Trial details

NCT IDNCT04911296

SponsorRANI Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-27

Results submitted2024-11-26

View on ClinicalTrials.gov More Not Determined trials

Who can participate

Age range21 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Successful Swallowing of the Mock-RP

Timeframe: Immediately after swallowing

Percent of Participants Who Would Chose a Pill Instead of Injection

Timeframe: Immediately after swallowing

Mock-RP Swallowing Experience

Timeframe: Immediately after swallowing

Mock-RP Swallowing Experience

Timeframe: Immediately after swallowing

Mock-RP Swallowing Experience

Timeframe: Immediately after swallowing

Adverse Events

Timeframe: Immediately after swallowing