Trial Outcomes & Findings for Pill Swallow Study (NCT NCT04911296)
NCT ID: NCT04911296
Last Updated: 2025-02-12
Results Overview
Percent of participants successfully swallowing the Mock-RP as reported on the questionnaire.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
Immediately after swallowing
Results posted on
2025-02-12
Participant Flow
Participant milestones
| Measure |
Swallow Group
Mock-RP: Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.
|
|---|---|
|
Overall Study
STARTED
|
150
|
|
Overall Study
COMPLETED
|
150
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sex stratified by age groups.
Baseline characteristics by cohort
| Measure |
Swallow Group
n=150 Participants
Mock-RP: Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.
|
|---|---|
|
Age, Customized
21 - 50 years
|
50 Participants
n=150 Participants
|
|
Age, Customized
51 - 65 years
|
50 Participants
n=150 Participants
|
|
Age, Customized
66 - 75 years
|
50 Participants
n=150 Participants
|
|
Sex: Female, Male
21 - 50 years · Female
|
29 Participants
n=50 Participants • Sex stratified by age groups.
|
|
Sex: Female, Male
21 - 50 years · Male
|
21 Participants
n=50 Participants • Sex stratified by age groups.
|
|
Sex: Female, Male
51 - 65 years · Female
|
28 Participants
n=50 Participants • Sex stratified by age groups.
|
|
Sex: Female, Male
51 - 65 years · Male
|
22 Participants
n=50 Participants • Sex stratified by age groups.
|
|
Sex: Female, Male
66 - 75 years · Female
|
28 Participants
n=50 Participants • Sex stratified by age groups.
|
|
Sex: Female, Male
66 - 75 years · Male
|
22 Participants
n=50 Participants • Sex stratified by age groups.
|
|
Sex: Female, Male
Total · Female
|
85 Participants
n=150 Participants • Sex stratified by age groups.
|
|
Sex: Female, Male
Total · Male
|
65 Participants
n=150 Participants • Sex stratified by age groups.
|
|
Race/Ethnicity, Customized
21 - 50 years · Black - Non-Hispanic
|
6 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
21 - 50 years · American Indian/Alaskan Native
|
1 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
21 - 50 years · Hispanic
|
32 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
21 - 50 years · Asian/Pacific Islander
|
0 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
21 - 50 years · White - Non-Hispanic
|
11 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
51 - 65 years · Black - Non-Hispanic
|
5 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
51 - 65 years · American Indian/Alaskan Native
|
1 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
51 - 65 years · Hispanic
|
28 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
51 - 65 years · Asian/Pacific Islander
|
0 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
51 - 65 years · White - Non-Hispanic
|
16 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
66 - 75 years · Black - Non-Hispanic
|
7 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
66 - 75 years · American Indian/Alaskan Native
|
0 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
66 - 75 years · Hispanic
|
24 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
66 - 75 years · Asian/Pacific Islander
|
2 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
66 - 75 years · White - Non-Hispanic
|
17 Participants
n=50 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
Total · Black - Non-Hispanic
|
18 Participants
n=150 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
Total · American Indian/Alaskan Native
|
2 Participants
n=150 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
Total · Hispanic
|
84 Participants
n=150 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
Total · Asian/Pacific Islander
|
2 Participants
n=150 Participants • Race stratified by age groups
|
|
Race/Ethnicity, Customized
Total · White - Non-Hispanic
|
44 Participants
n=150 Participants • Race stratified by age groups
|
|
Region of Enrollment
Australia
|
150 Participants
n=150 Participants
|
|
BMI
21 - 50 years
|
35.54 kg/m^2
n=50 Participants • BMI stratified by age groups
|
|
BMI
51 - 65 years
|
34.87 kg/m^2
n=50 Participants • BMI stratified by age groups
|
|
BMI
66 - 75 years
|
32.93 kg/m^2
n=50 Participants • BMI stratified by age groups
|
|
BMI
Total
|
34.45 kg/m^2
n=150 Participants • BMI stratified by age groups
|
PRIMARY outcome
Timeframe: Immediately after swallowingPercent of participants successfully swallowing the Mock-RP as reported on the questionnaire.
Outcome measures
| Measure |
Swallow Group
n=150 Participants
Mock-RP: Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.
|
1-5 Years
How long have you been taking injections for your condition?
|
>5 Years
How long have you been taking injections for your condition?
|
Monthly
Injection Frequency
|
|---|---|---|---|---|
|
Successful Swallowing of the Mock-RP
|
150 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Immediately after swallowingAssess if a participant would choose a pill instead of their current injection therapy if a pill becomes available.
Outcome measures
| Measure |
Swallow Group
n=150 Participants
Mock-RP: Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.
|
1-5 Years
How long have you been taking injections for your condition?
|
>5 Years
How long have you been taking injections for your condition?
|
Monthly
Injection Frequency
|
|---|---|---|---|---|
|
Percent of Participants Who Would Chose a Pill Instead of Injection
|
136 Participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Immediately after swallowingParticipant experience with swallowing Mock-RP stratified by number of years using injections.
Outcome measures
| Measure |
Swallow Group
n=16 Participants
Mock-RP: Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.
|
1-5 Years
n=59 Participants
How long have you been taking injections for your condition?
|
>5 Years
n=75 Participants
How long have you been taking injections for your condition?
|
Monthly
Injection Frequency
|
|---|---|---|---|---|
|
Mock-RP Swallowing Experience
Easy
|
12 Participants
|
46 Participants
|
56 Participants
|
—
|
|
Mock-RP Swallowing Experience
Large Pill - Easy
|
3 Participants
|
8 Participants
|
14 Participants
|
—
|
|
Mock-RP Swallowing Experience
Challenging Due to Size
|
1 Participants
|
3 Participants
|
4 Participants
|
—
|
|
Mock-RP Swallowing Experience
No Comment
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: Immediately after swallowingParticipants' experience with swallowing Mock-RP was stratified by age (21-50, 51-65, 66-75 years).
Outcome measures
| Measure |
Swallow Group
n=50 Participants
Mock-RP: Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.
|
1-5 Years
n=50 Participants
How long have you been taking injections for your condition?
|
>5 Years
n=50 Participants
How long have you been taking injections for your condition?
|
Monthly
Injection Frequency
|
|---|---|---|---|---|
|
Mock-RP Swallowing Experience
Easy
|
36 Participants
|
37 Participants
|
41 Participants
|
—
|
|
Mock-RP Swallowing Experience
Large Pill - Easy
|
10 Participants
|
9 Participants
|
6 Participants
|
—
|
|
Mock-RP Swallowing Experience
Challenging Due to Size
|
4 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Mock-RP Swallowing Experience
No Comment
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
PRIMARY outcome
Timeframe: Immediately after swallowingParticipants 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.
Outcome measures
| Measure |
Swallow Group
n=102 Participants
Mock-RP: Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.
|
1-5 Years
n=2 Participants
How long have you been taking injections for your condition?
|
>5 Years
n=36 Participants
How long have you been taking injections for your condition?
|
Monthly
n=10 Participants
Injection Frequency
|
|---|---|---|---|---|
|
Mock-RP Swallowing Experience
No
|
10 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Mock-RP Swallowing Experience
Yes
|
92 Participants
|
2 Participants
|
34 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Immediately after swallowingAll adverse events categorized by type and frequency.
Outcome measures
| Measure |
Swallow Group
n=150 Participants
Mock-RP: Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.
|
1-5 Years
How long have you been taking injections for your condition?
|
>5 Years
How long have you been taking injections for your condition?
|
Monthly
Injection Frequency
|
|---|---|---|---|---|
|
Adverse Events
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
Swallow Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sr. Director of Clinical Operations
Rani Therapeutics
Phone: +1 (408) 457-3700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place