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A prospective, single-center, open-label, single-arm, observational study assessing participant experience with swallowing the Mock-RP
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Swallow Group | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mock-RP | Other | Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials of Texas | San Antonio | Texas | 78229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Swallow Group | Mock-RP: Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Swallow Group | Mock-RP: Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Successful Swallowing of the Mock-RP | Percent of participants successfully swallowing the Mock-RP as reported on the questionnaire. | Posted | Count of Participants | Participants | Immediately after swallowing |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Swallow Group | Mock-RP: Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director of Clinical Operations | Rani Therapeutics | +1 (408) 457-3700 | joshua.myers@ranitherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 24, 2021 | Jan 22, 2025 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Sex stratified by age groups. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race stratified by age groups | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| BMI | BMI stratified by age groups | Mean | Full Range | kg/m^2 |
|
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| Primary | 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. | Posted | Count of Participants | Participants | Immediately after swallowing |
|
|
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| Primary | Mock-RP Swallowing Experience | Participant experience with swallowing Mock-RP stratified by number of years using injections. | Posted | Count of Participants | Participants | Immediately after swallowing |
|
|
|
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| Primary | Mock-RP Swallowing Experience | Participants' experience with swallowing Mock-RP was stratified by age (21-50, 51-65, 66-75 years). | Posted | Count of Participants | Participants | Immediately after swallowing |
|
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | Immediately after swallowing |
|
|
|
| Primary | Adverse Events | All adverse events categorized by type and frequency. | Posted | Count of Participants | Participants | Immediately after swallowing |
|
|
|
| 0 |
| 150 |
| 0 |
| 150 |
| 0 |
| 150 |
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| Asian/Pacific Islander |
|
| White - Non-Hispanic |
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| Asian/Pacific Islander |
|
| White - Non-Hispanic |
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| Asian/Pacific Islander |
|
| White - Non-Hispanic |
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| Challenging Due to Size |
|
| No Comment |
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| Challenging Due to Size |
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| No Comment |
|
| Yes |
|