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OpenTrials
Completed

NCT Number: NCT04911296

Pill Swallow Study

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

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Key information

Conditions

Not Determined

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mock-RP

Other

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

Primary outcomes

  1. Successful Swallowing of the Mock-RP

    Time frame: Immediately after swallowing

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

  2. Percent of Participants Who Would Chose a Pill Instead of Injection

    Time frame: Immediately after swallowing

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

  3. Mock-RP Swallowing Experience

    Time frame: Immediately after swallowing

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

  4. Mock-RP Swallowing Experience

    Time frame: Immediately after swallowing

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

  5. Mock-RP Swallowing Experience

    Time frame: 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.

  6. Adverse Events

    Time frame: Immediately after swallowing

    All adverse events categorized by type and frequency.

Sponsors and collaborators

Lead sponsor

RANI Therapeutics

Industry

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 3, 2021
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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