N/A
N=150
Pill Swallow Study
Not Determined
Bottom Line
View on ClinicalTrials.gov: NCT04911296 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Successful Swallowing of the Mock-RP — 150 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mock-RP (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- RANI Therapeutics
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Successful Swallowing of the Mock-RP |
150 | — |
| PRIMARY Percent of Participants Who Would Chose a Pill Instead of Injection |
136 | — |
| PRIMARY Mock-RP Swallowing Experience |
10; 0; 2; 2; 92; 2 | — |
| PRIMARY Mock-RP Swallowing Experience |
10; 0; 2; 2; 92; 2 | — |
| PRIMARY Mock-RP Swallowing Experience |
10; 0; 2; 2; 92; 2 | — |
| PRIMARY Adverse Events |
— | — |
Summary
A prospective, single-center, open-label, single-arm, observational study assessing participant experience with swallowing the Mock-RP
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04911296). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.