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Placebo for Overactive Bladder Syndrome
Phase 2
Waitlist Available
Research Sponsored by Urovant Sciences GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and at week 12
Awards & highlights
Study Summary
This trial will study how safe and effective a single dose of URO-902 is for people with overactive bladder and urge urinary incontinence.
Eligible Conditions
- Overactive Bladder Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (day 1) and at week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and at week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes
Secondary outcome measures
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Trial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: URO-902 48 mg; PlaceboExperimental Treatment2 Interventions
Participants will receive either a single treatment of URO-902 48 mg or matching placebo.
Group II: Cohort 1: URO-902 24 mg; PlaceboExperimental Treatment2 Interventions
Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
URO-902
2019
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
Urovant Sciences GmbHLead Sponsor
10 Previous Clinical Trials
4,184 Total Patients Enrolled
Hanh Badger, PharmDStudy DirectorUrovant Sciences
1 Previous Clinical Trials
14 Total Patients Enrolled
Frequently Asked Questions
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