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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: URO-902 24 mg; Placebo | Experimental | Participants will receive either a single treatment of URO-902 24 milligrams (mg) or matching placebo. |
|
| Cohort 2: URO-902 48 mg; Placebo | Experimental | Participants will receive either a single treatment of URO-902 48 mg or matching placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| URO-902 | Drug | intradetrusor injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes | 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. | Baseline (Day 1) and at Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hanh Badger, PharmD | Urovant Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Clinical Research Inc | Mobile | Alabama | 36608 | United States | ||
| Urological Associates of Southern Arizona |
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A total of 80 participants were randomized into the study.
This multicenter, randomized, double-blind, placebo-controlled, single-treatment, 2-cohort, dose escalation study evaluated the efficacy and safety of URO-902 in females with overactive bladder (OAB) and Urge Urinary Incontinence (UUI).
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 milligrams (mg) or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy. |
| FG001 | URO-902 24 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 19, 2021 | Mar 29, 2023 |
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| Placebo | Drug | intradetrusor injection |
|
| Up to Week 48 |
| Tucson |
| Arizona |
| 85715 |
| United States |
| Orange County Urology Associates | Laguna Hills | California | 92653 | United States |
| University of Southern California - Norris Hospital | Los Angeles | California | 90033 | United States |
| Tri Valley Urology Medical Group | Murrieta | California | 92562 | United States |
| Stanford University School of Medicine | Palo Alto | California | 94304 | United States |
| Precision Clinical Research LLC | Sunrise | Florida | 33351 | United States |
| Iowa Clinic | West Des Moines | Iowa | 50266 | United States |
| Chesapeake Urology Associates | Hanover | Maryland | 21076 | United States |
| Bay State Clinical Trials | Watertown | Massachusetts | 02472 | United States |
| Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| Premier Urology Group, LLC | Edison | New Jersey | 08837 | United States |
| Urology Center of Englewood | Englewood | New Jersey | 07631 | United States |
| Great Lakes Physician PC / Western New York Urology Associates | Cheektowaga | New York | 14225 | United States |
| Accumed Research Associates - ClinEdge - PPDS | Garden City | New York | 11530 | United States |
| Atrium Healthcare | Charlotte | North Carolina | 28203 | United States |
| Urology Specialists of The Carolinas | Huntersville | North Carolina | 28078 | United States |
| Institute For Female Pelvic Medicine | Allentown | Pennsylvania | 18104 | United States |
| Urology of Virginia | Virginia Beach | Virginia | 23462 | United States |
| Washington Urology & Urogynecology Associates | Kirkland | Washington | 98034 | United States |
Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy.
| FG002 | URO-902 48 mg | Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 48 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy. |
| COMPLETED |
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| NOT COMPLETED |
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Intent- to-treat Exposed (ITT-E) population was defined as all participants who were randomized and treated.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 milligrams (mg) or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy. |
| BG001 | URO-902 24 mg | Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy. |
| BG002 | URO-902 48 mg | Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 48 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline at Week 12 in Average Daily Number of Urgency Episodes | 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. | ITT-E Population. Only those participants with data available at the specified data points were analyzed. | Posted | Least Squares Mean | Standard Error | Urgency episodes per day | Baseline (Day 1) and at Week 12 |
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| Secondary | Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | 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. | Safety Population comprises of all participants who were randomized and received study drug. | Posted | Count of Participants | Participants | Up to Week 48 |
|
Up to 48 Weeks
Treatment emergent adverse events (TEAEs) and Treatment emergent serious adverse events (TESAEs) were collected in Safety Population. Safety Population comprised of all participants who were randomized and received study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 milligrams (mg) or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy. | 0 | 26 | 3 | 26 | 14 | 26 |
| EG001 | URO-902 24 mg | Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy. | 0 | 22 | 1 | 22 | 10 | 22 |
| EG002 | URO-902 48 mg | Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 48 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy. | 0 | 26 | 2 | 26 | 14 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cervical radiculopathy | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Hypertension | General disorders | MedDra 25.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Bacteriuria | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDra 25.0 | Systematic Assessment |
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| Gastrointestinal bacterial overgrowth | Infections and infestations | MedDra 25.0 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDra 25.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDra 25.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDra 25.0 | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
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| Leukocyturia | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
| |
| Urinary hesitation | Renal and urinary disorders | MedDra 25.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
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| Bursitis | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
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| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
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| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDra 25.0 | Systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDra 25.0 | Systematic Assessment |
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| Device intolerance | General disorders | MedDra 25.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDra 25.0 | Systematic Assessment |
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| Suprapubic pain | General disorders | MedDra 25.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
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| Hiatus hernia | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDra 25.0 | Systematic Assessment |
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| Clavicle fracture | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
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| Limb injury | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
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| Patella fracture | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
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| Rib fracture | Injury, poisoning and procedural complications | MedDra 25.0 | Systematic Assessment |
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| ECG signs of myocardial infarction | Investigations | MedDra 25.0 | Systematic Assessment |
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| Electrocardiogram QT prolonged | Investigations | MedDra 25.0 | Systematic Assessment |
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| Electrocardiogram abnormal | Investigations | MedDra 25.0 | Systematic Assessment |
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| Residual urine volume increased | Investigations | MedDra 25.0 | Systematic Assessment |
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| Chronic left ventricular failure | Cardiac disorders | MedDra 25.0 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDra 25.0 | Systematic Assessment |
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| Vitamin D deficiency | Metabolism and nutrition disorders | MedDra 25.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
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| Cervical radiculopathy | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDra 25.0 | Systematic Assessment |
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| Atrophic vulvovaginitis | Reproductive system and breast disorders | MedDra 25.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
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| Asthma | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
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| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDra 25.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDra 25.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDra 25.0 | Systematic Assessment |
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| Hot flush | Vascular disorders | MedDra 25.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDra 25.0 | Systematic Assessment |
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| Bipolar disorder | Psychiatric disorders | MedDra 25.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDra 25.0 | Systematic Assessment |
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The Sponsor does not object to publication by Institution or Principal Investigator (PI) of results of the Trial based on information collected or generated by the Institution or PI. However, the Institution and PI are required to provide the Sponsor with an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed to ensure against any inadvertent disclosure of Sponsor Confidential Information or unprotected Sponsor Inventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Information, Clinical Trial Results | Urovant Sciences | 949-226-6029 | info@urovant.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 21, 2022 | Mar 29, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Mixed model for repeated measures |
| =0.0159 |
| Least Square Mean Difference |
| -2.24 |
| 2-Sided |
| 95 |
| -4.04 |
| -0.43 |
Treatment comparison between Placebo and URO-902 48 mg using least sqaure mean difference and 95% CI has been presented. |
| Other |
Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 24 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy. |
| OG002 | URO-902 48 mg | Participants were sequentially randomized in a 2:1 ratio to receive either URO-902 48 mg or placebo as a single treatment, administered by intra-detrusor injections via cystoscopy. |
|
|