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NCT04211831 · ClinicalTrials.gov registry record · Phase 2
URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
A Phase 2 study, sponsored by Urovant Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT04211831: Completed Phase 2 study, sponsored by Urovant Sciences.
NCT04211831 is a Phase 2 study that has completed, run by Urovant Sciences. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04211831, a Phase 2 study, has completed, sponsored by Urovant Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose.
Primary Outcome
Average daily number of urgency episodes was calculated as the total number of urgency episodes recorded on a completed diary day within the visit window divided by the number of days the Bladder Diary was filled out. An urgency episode was defined as when a participant answered "Yes" to the question "Need to urinate immediately" on the bladder diary electronic case report form (eCRF). If a participant had more than 1 bladder diary filled out on the same day, then all the urgency episodes were s
Interventions
- DRUG Placebo
- DRUG URO-902
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2019-12-16 |
| Est. Completion | 2022-07-20 |
| Phase | Phase 2 |
What the finished NCT04211831 record still lists
NCT04211831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04211831 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04211831 about?
NCT04211831 is a clinical study titled "URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence". This study will evaluate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose.
What is the current status of trial NCT04211831?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2019-12-16. Estimated completion is 2022-07-20.
What interventions are being tested in trial NCT04211831?
The interventions under investigation include: Placebo (DRUG), URO-902 (DRUG).
Who is sponsoring clinical trial NCT04211831?
This trial is sponsored by Urovant Sciences, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04211831's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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