URO-902 in Female Subjects With Overactive Bladder and Urge Urinary Incontinence
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04211831 |
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Recruitment Status :
Recruiting
First Posted : December 26, 2019
Last Update Posted : May 5, 2021
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Sponsor:
Urovant Sciences GmbH
Information provided by (Responsible Party):
Urovant Sciences GmbH
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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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 78 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 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | September 2022 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cohort 1: URO-902 24 mg; Placebo
Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo.
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Drug: URO-902
intradetrusor injection
Other Names:
Drug: Placebo intradetrusor injection |
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Experimental: Cohort 2: URO-902 48 mg; Placebo
Participants will receive either a single treatment of URO-902 48 mg or matching placebo.
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Drug: URO-902
intradetrusor injection
Other Names:
Drug: Placebo intradetrusor injection |
Primary Outcome Measures :
- Change from Baseline at Week 12 in average daily number of Urge Urinary Incontinence (UUI) episodes [ Time Frame: Baseline; Week 12 ]
Secondary Outcome Measures :
- Number of participants with any adverse event [ Time Frame: up to Week 48 ]
Information from the National Library of Medicine
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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)
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
Contacts
| Contact: Urovant Call Center | (833) 876-8268 | clinicaltrials@urovant.com |
Locations
Show 18 study locations
Sponsors and Collaborators
Urovant Sciences GmbH
Investigators
| Study Director: | Hanh Badger, PharmD | Urovant Sciences |
| Responsible Party: | Urovant Sciences GmbH |
| ClinicalTrials.gov Identifier: | NCT04211831 |
| Other Study ID Numbers: |
URO-902-2001 |
| First Posted: | December 26, 2019 Key Record Dates |
| Last Update Posted: | May 5, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Urovant Sciences GmbH:
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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 |
Lower Urinary Tract Symptoms Urological Manifestations Behavioral Symptoms Elimination Disorders Mental Disorders Urinary Bladder Diseases |