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Trial record 1 of 1 for:    urovant | URO-902
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URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence

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ClinicalTrials.gov Identifier: NCT04211831
Recruitment Status : Recruiting
First Posted : December 26, 2019
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Urovant Sciences GmbH

Tracking Information
First Submitted Date  ICMJE December 23, 2019
First Posted Date  ICMJE December 26, 2019
Last Update Posted Date August 17, 2020
Actual Study Start Date  ICMJE December 16, 2019
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2019)
Change from Baseline at Week 12 in average daily number of Urge Urinary Incontinence (UUI) episodes [ Time Frame: Baseline; Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2019)
Number of participants with any adverse event [ Time Frame: up to Week 48 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
Official Title  ICMJE An Exploratory Phase 2a Study Evaluating the Efficacy and Safety of URO-902 in Subjects With Overactive Bladder and Urge Urinary Incontinence
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Overactive Bladder With Urge Urinary Incontinence
Intervention  ICMJE
  • Drug: URO-902
    intradetrusor injection
    Other Names:
    • hMaxi-K
    • pVAX/hSlo
  • Drug: Placebo
    intradetrusor injection
Study Arms  ICMJE
  • Experimental: Cohort 1: URO-902 24 mg; Placebo
    Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo.
    Interventions:
    • Drug: URO-902
    • Drug: Placebo
  • Experimental: Cohort 2: URO-902 48 mg; Placebo
    Participants will receive either a single treatment of URO-902 48 mg or matching placebo.
    Interventions:
    • Drug: URO-902
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 23, 2019)
78
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Urovant Call Center (833) 876-8268 clinicaltrials@urovant.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04211831
Other Study ID Numbers  ICMJE URO-902-2001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Urovant Sciences GmbH
Study Sponsor  ICMJE Urovant Sciences GmbH
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Jihao Zhou, MD, PhD Urovant Sciences
PRS Account Urovant Sciences GmbH
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP