Pill Swallow Study

NCT04911296 | Completed Results

• 1 other identifier: CP-0003
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Not Determined

Outcome Measures

Primary Outcomes (6)

• Successful Swallowing of the Mock-RP

  Percent of participants successfully swallowing the Mock-RP as reported on the questionnaire.

  Immediately after swallowing

• Percent of Participants Who Would Chose a Pill Instead of Injection

  Assess if a participant would choose a pill instead of their current injection therapy if a pill becomes available.

  Immediately after swallowing

• Mock-RP Swallowing Experience

  Participant experience with swallowing Mock-RP stratified by number of years using injections.

  Immediately after swallowing

• Mock-RP Swallowing Experience

  Participants' experience with swallowing Mock-RP was stratified by age (21-50, 51-65, 66-75 years).

  Immediately after swallowing

• Mock-RP Swallowing Experience

  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.

  Immediately after swallowing

• Adverse Events

  All adverse events categorized by type and frequency.

  Immediately after swallowing

Study Arms (1)

Swallow Group

OTHER

Other: Mock-RP

Interventions

Mock-RP OTHER

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

Swallow Group

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RANI Therapeutics: lead

Study Sites (1)

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

Results Point of Contact

• Title: Sr. Director of Clinical Operations
• Organization: Rani Therapeutics

joshua.myers@ranitherapeutics.com

+1 (408) 457-3700

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 3, 2021
• Study Start: June 1, 2021
• Primary Completion: August 27, 2021
• Study Completion: August 27, 2021
• Last Updated: February 12, 2025
• Results First Posted: February 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)