Not DeterminedNCT04911296
Pill Swallow Study
A study testing Mock-RP in people with Not Determined, run by RANI Therapeutics at 1 site in United States.
Trial summary
A prospective, single-center, open-label, single-arm, observational study assessing participant experience with swallowing the Mock-RP Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Not Determined
- What is being tested?
- Mock-RP
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2021to 27 Aug 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
A prospective, single-center, open-label, single-arm, observational study assessing participant experience with swallowing the Mock-RP
- Conditions
- Not Determined
- Being tested
- Mock-RP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mock-RPOther
Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.
| Study group | Role | What they receive |
|---|---|---|
| Swallow Group | Other | Not described Receives: Other: Mock-RP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Swallowing of the Mock-RP
Percent of participants successfully swallowing the Mock-RP as reported on the questionnaire.
Measured: 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.
Measured: Immediately after swallowing
Mock-RP Swallowing Experience
Participant experience with swallowing Mock-RP stratified by number of years using injections.
Measured: Immediately after swallowing
Mock-RP Swallowing Experience
Participants' experience with swallowing Mock-RP was stratified by age (21-50, 51-65, 66-75 years).
Measured: 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.
Measured: Immediately after swallowing
Adverse Events
All adverse events categorized by type and frequency.
Measured: Immediately after swallowing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start1 Jun 2021
- Primary completion27 Aug 2021
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Not DeterminedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- RANI Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911296
- Sponsor's protocol ID
- CP-0003
- Status last verified
- Jan 2025
- First submitted
- 27 May 2021
- Last updated
- 12 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pill Swallow Study
- ClinicalTrials.gov ID
- NCT04911296
- Acronym / sponsor ID
- CP-0003
- Conditions
- Not Determined
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- RANI TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 3 Jun 2021 (actual)
- Results
- Posted 12 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single-center, open-label, single-arm, observational study assessing participant experience with swallowing the Mock-RP
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Swallow Group | Other | Other: Mock-RP |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mock-RPStandard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating. | Other | Swallow Group |
Primary outcome
Successful Swallowing of the Mock-RP
Time frame: 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
Time frame: 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
Time frame: Immediately after swallowing
Participant experience with swallowing Mock-RP stratified by number of years using injections.
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).
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.
Adverse Events
Time frame: Immediately after swallowing
All adverse events categorized by type and frequency.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mock-RP in people with Not Determined, run by RANI Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Swallowing of the Mock-RP (time frame: Immediately after swallowing). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.