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URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04211831
Recruitment Status : Completed
First Posted : December 26, 2019
Results First Posted : April 20, 2023
Last Update Posted : April 20, 2023
Sponsor:
Information provided by (Responsible Party):
Urovant Sciences GmbH

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder With Urge Urinary Incontinence Drug: URO-902 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory Phase 2a Study Evaluating the Efficacy and Safety of URO-902 in Subjects With Overactive Bladder and Urge Urinary Incontinence
Actual Study Start Date : December 16, 2019
Actual Primary Completion Date : November 18, 2021
Actual Study Completion Date : July 20, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1: URO-902 24 mg; Placebo
Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo.
 Drug: URO-902
intradetrusor injection
Other Names:
  • hMaxi-K
  • pVAX/hSlo

Drug: Placebo
intradetrusor injection
Experimental: Cohort 2: URO-902 48 mg; Placebo
Participants will receive either a single treatment of URO-902 48 mg or matching placebo.
 Drug: URO-902
intradetrusor injection
Other Names:
  • hMaxi-K
  • pVAX/hSlo

Drug: Placebo
intradetrusor injection


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes [ Time Frame: Baseline (Day 1) and at Week 12 ]
    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 summed together. The denominator used for calculating the average number only counted the days in which there was at least 1 completed bladder diary day within the visit window. Baseline was defined as the last non-missing measurement prior to the study treatment. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.


Secondary Outcome Measures :
  1. Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) [ Time Frame: Up to Week 48 ]
    An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant, administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize participant and may require medical or surgical intervention to prevent any of outcomes listed above. TEAEs/TESAEs are defined as any event that began or worsened in severity after initial exposure of study treatment through 48 weeks after treatment administration or the date of the initiation of another overactive bladder medication, investigational agent, or surgical intervention, whichever occurred first.


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant has symptoms of Overactive Bladder (OAB) (frequency and urgency) with Urge Urinary Incontinence (UUI) for a period of at least 6 months prior to screening.
  • Participant experiences ≥ 1 episode of UUI per day.
  • Participant has not been adequately managed with ≥ 1 oral or transdermal pharmacologic therapies for the treatment of their OAB symptoms.

Exclusion Criteria:

  • Participant has symptoms of OAB due to any known neurological reason (e.g., spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc).
  • Participant has a predominance of stress incontinence in the opinion of the investigator, determined by participant history.
  • Participant currently uses or plans to use medications or therapies to treat symptoms of OAB, including nocturia.
  • Participants who have previously been treated with onabotulinumtoxinA for urological indications within 12 months of starting the Screening Bladder Diary, or any other toxin for urological indications, regardless of when treated (participants treated with onabotulinumtoxinA or other toxins for non-urological indications are eligible, regardless of when treated)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04211831


Locations
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Sponsors and Collaborators
Urovant Sciences GmbH
Investigators
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Study Director: Hanh Badger, PharmD Urovant Sciences
  Study Documents (Full-Text)

Documents provided by Urovant Sciences GmbH:
Study Protocol  [PDF] February 19, 2021
Statistical Analysis Plan  [PDF] July 21, 2022

More Information
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Responsible Party: Urovant Sciences GmbH
ClinicalTrials.gov Identifier: NCT04211831    
Other Study ID Numbers: URO-902-2001
First Posted: December 26, 2019    Key Record Dates
Results First Posted: April 20, 2023
Last Update Posted: April 20, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Urovant Sciences GmbH:
URO-902
hMaxi-K
pVAX/hSlo
Overactive Bladder
Urge Urinary Incontinence
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Male Urogenital Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases