Pill Swallow Study

• Sponsor: RANI Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04911296
• Collaborator: (none)
• Enrollment: 152
• Location: 1
• Arm: 1
• Actual Duration (Months): 2.9
• Patients Per Site Per Month: 53.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Not Determined	Other: Mock-RP	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 152 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Pill Swallow Study
• Actual Study Start Date: Jun 1, 2021
• Actual Primary Completion Date: Aug 27, 2021
• Actual Study Completion Date: Aug 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Swallow Group	Other: Mock-RP; Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.

Outcome Measures

Primary Outcome Measures

1. Percent of participants successfully swallowing the Mock-RP as reported on the questionnaire. [Immediately after swallowing]

2. Assess if participant would choose a pill instead of their current injection therapy if a pill becomes available. [Immediately after swallowing]

3. Participant experience with swallowing Mock-RP stratified by number of years using injections. [Immediately after swallowing]

4. Participant experience with swallowing Mock-RP stratified by age (21-50, 51-65, 66-75 years). [Immediately after swallowing]

5. Participant experience with swallowing Mock-RP stratified by frequency of injection treatment. [Immediately after swallowing]

6. All adverse events categorized by type and frequency. [Immediately after swallowing]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trials of Texas	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• RANI Therapeutics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RANI Therapeutics
• ClinicalTrials.gov Identifier: NCT04911296
• Other Study ID Numbers: CP-0003
• First Posted: Jun 3, 2021
• Last Update Posted: Sep 16, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 16, 2021