Pill Swallow Study

Not Applicable

Completed

• Conditions: Not Determined
• Interventions: Other: Mock-RP

• Registration Number: NCT04911296
• Lead Sponsor: RANI Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-27
• Study Start: 2021-06-01
• Study First Submitted QC: 2021-06-01
• Study First Posted: 2021-06-03
• Primary Completion: 2021-08-27
• Study Completion: 2021-08-27
• Results First Submitted: 2024-11-26
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-22
• Last Update Submitted: 2025-01-22
• Results First Posted: 2025-02-12
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Swallow Group	Mock-RP	-

Primary Outcome Measures

Name	Time	Method
Successful Swallowing of the Mock-RP	Immediately after swallowing	Percent of participants successfully swallowing the Mock-RP as reported on the questionnaire.
Percent of Participants Who Would Chose a Pill Instead of Injection	Immediately after swallowing	Assess if a participant would choose a pill instead of their current injection therapy if a pill becomes available.
Mock-RP Swallowing Experience	Immediately after swallowing	Participants completed a questionnaire after swallowing the Mock-RP stating if they would select a pill alternative over their current injections - stratified by frequency of injection treatment.
Adverse Events	Immediately after swallowing	All adverse events categorized by type and frequency.

Trial Locations

Locations (1)

Clinical Trials of Texas; 🇺🇸 San Antonio, Texas, United States