Clinical trial NCT03492281: A Study to Examine the Safety and Efficacy of a New Drug in Patients With Symptoms of Overactive Bladder (OAB)
Official title: An International Phase 3, Randomized, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Multicenter Study to Evaluate the Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: Beta-3 adrenergic receptor (β3-AR) agonists
Incontinence
OAB
Vibegron
Urge urinary incontinence
Urinary bladder, overactive
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Agents
Lead sponsor: Urovant Sciences GmbH
Sponsor class: INDUSTRY
First posted: 2018-04-10
Enrollment: 1530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in patients with OAB.


Eligibility criteria: Inclusion Criteria:

1. Has a history of OAB for at least 3 months prior to the Screening Visit.
2. Meets either the OAB Wet or OAB Dry criteria.

Exclusion Criteria:

Urology Medical History

1. Patient had an average total daily urine volume \> 3000 mL in the past 6 months or during the 14-day Run-in Period.
2. Has lower urinary tract pathology that could, in the opinion of the Investigator, be responsible for urgency, frequency, or incontinence.
3. Has a history of surgery to correct stress urinary incontinence, pelvic organ prolapse, or procedural treatments for BPH within 6 months of Screening.
4. Has current history or evidence of Stage 2 or greater pelvic organ prolapse (prolapse extends beyond the hymenal ring).
5. Patient is currently using a pessary for the treatment of pelvic organ prolapse.
6. Has a known history of elevated post-void residual volume defined as greater than 150 mL.
7. Has undergone bladder training or electrostimulation within 28 days prior to Screening or plans to initiate either during the study.
8. Has an active or recurrent (\> 3 episodes per year) urinary tract infection by clinical symptoms or pre-defined laboratory criteria.
9. Has a requirement for an indwelling catheter or intermittent catheterization.
10. Has received an intradetrusor injection of botulinum toxin within 9 months prior to Screening.
11. Has uncontrolled hyperglycemia (defined as fasting blood glucose \> 150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose \> 200 mg/dL or 11.1 mmol/L) or, if in the opinion of the Investigator, is uncontrolled.
12. Has evidence of diabetes insipidus.
13. Is pregnant, breast-feeding, or is planning to conceive within the projected duration of the study.
14. Has a concurrent malignancy or history of any malignancy within 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
15. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mmHg and/or diastolic blood pressure of ≥ 100 mmHg) or has a resting heart rate (by pulse) \> 100 beats per minute.
16. Has narrow angle glaucoma (primary open angle glaucoma is not excluded).
17. Has a history of cerebral vascular accident, transient ischemic attack, unstable angina, myocardial infarction, coronary artery interventions (e.g., coronary artery bypass grafting or percutaneous coronary interventions \[e.g., angioplasty, stent insertion\]), or neurovascular interventions (e.g., carotid artery stenting) within 6 months prior to the Screening Visit. Has a known history of liver disease.
18. Has a history of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis, Parkinson's) that could affect the lower urinary tract or its nerve supply.
19. Has hematuria, including microscopic hematuria according to pre-defined criteria.
20. Has clinically significant electrocardiogram (ECG) abnormality.
21. Has alanine aminotransferase or aspartate aminotransferase \> 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) \> 1.5 x ULN (or \> 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome).
22. Has an estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2.
23. Has an allergy, intolerance, or a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of the vibegron formulation or tolterodine formulation.
24. Is currently participating or has participated in a study with an investigational compound or device within 28 days prior to signing informed consent, or has participated in any previous study with vibegron.

Primary outcomes:
measure: Change From Baseline (CFB) at Week 12 in the Average Number of Micturitions Per 24 Hours in All Overactive Bladder (OAB) Participants
timeFrame: Baseline (BL); Week 12
measure: CFB at Week 12 in the Average Number of Urge Urinary Incontinence (UUI) Episodes Per 24 Hours in OAB Wet Participants
timeFrame: Baseline; Week 12
Secondary outcomes:
measure: CFB at Week 12 in the Average Number of Urgency Episodes Over 24 Hours in All OAB Participants
timeFrame: Baseline; Week 12
measure: Percentage of OAB Wet Participants With at Least a 75% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12
timeFrame: Baseline; Week 12
measure: Percentage of OAB Wet Participants With a 100% Reduction From Baseline in UUI Episodes Per 24 Hours at Week 12
timeFrame: Baseline; Week 12
measure: Percentage of All OAB Participants With at Least a 50% Reduction From Baseline in Urgency Episodes Per 24 Hours at Week 12
timeFrame: Baseline; Week 12
measure: CFB at Week 12 in the Average Number of Total Incontinence Episodes Over 24 Hours in OAB Wet Participants
timeFrame: Baseline; Week 12
measure: CFB at Week 12 in the Coping Score From the Overactive Bladder Questionnaire Long Form (OAB-q LF, 1-week Recall) in All OAB Participants
timeFrame: Baseline; Week 12
measure: CFB at Week 12 in the Average Volume Voided Per Micturition in All OAB Participants
timeFrame: Baseline; Week 12
measure: CFB at Week 12 in the Health-related Quality of Life (HRQL) Total Score From the OAB-q LF (1-week Recall) in All OAB Participants
timeFrame: Baseline; Week 12
measure: CFB at Week 12 in the Symptom Bother Score From the OAB-q LF (1-week Recall) in All OAB Participants
timeFrame: Baseline; Week 12
measure: Percentage of All OAB Participants With an Average Number of Micturitions < 8 Per 24 Hours at Week 12
timeFrame: Week 12
measure: Percentage of OAB Wet Participants With at Least a 50% Reduction From Baseline in Total Incontinence Episodes Per 24 Hours at Week 12
timeFrame: Baseline; Week 12
measure: CFB at Week 12 in Overall Bladder Symptoms Based on Patient Global Impression of Severity (PGI-Severity) in All OAB Participants
timeFrame: Baseline; Week 12
measure: CFB at Week 12 in Overall Control Over Bladder Symptoms Based on Patient Global Impression of Control (PGI-Control) in All OAB Participants
timeFrame: Baseline; Week 12
Other outcomes:
Locations:
city: Birmingham
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state: Alabama
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facility: Long Beach Clinical Trials LLC
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city: Los Angeles
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facility: Downtown L.A. Research Center Inc.
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city: Los Angeles
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facility: Urology Group of Southern California
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city: Murrieta
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facility: Tri Valley Urology Medical Group
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city: Sacramento
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facility: Northern California Research
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facility: San Bernadino Urological Associates
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city: Hialeah
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facility: Vital Pharm Research Inc.
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city: Jupiter
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facility: Health Awareness, Inc.
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city: Miami
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facility: San Marcus Research Clinic Inc.
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city: Miami
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facility: LCC Medical Research Institute Inc.
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city: Miami
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city: Miami
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facility: AppleMed Research Group LLC
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city: Miami
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facility: Miami Clinical Research
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city: Miami
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facility: Advanced Medical Research Institute
state: Florida
city: New Port Richey
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facility: Suncoast Clinical Research Inc.
state: Florida
city: New Port Richey
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facility: Bayside Clinical Research
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city: Orlando
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facility: Compass Research LLC
state: Florida
city: Pembroke Pines
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facility: South Broward Research LLC
state: Florida
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Pinellas Urology
state: Florida
city: Spring Hill
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facility: Meridien Research
state: Florida
city: Tampa
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facility: Clinical Research of West Florida
state: Florida
city: The Villages
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facility: Bioclinica Research
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city: Weeki Wachee
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facility: Asclepes Research Centers
state: Florida
city: Winter Haven
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facility: Clinical Research of Central Florida
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city: Peachtree Corners
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facility: In-Quest Medical Research, LLC
state: Georgia
city: Savannah
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facility: Meridian Clinical Research LLC
state: Georgia
city: Stockbridge
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facility: Clinical Research Atlanta
state: Georgia
city: Woodstock
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facility: North Georgia Clinical Research
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city: Blackfoot
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city: Meridian
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city: Gurnee
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city: Brownsburg
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city: Evansville
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city: Wichita
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facility: Heartland Research Associates LLC
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city: Lexington
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facility: Central Kentucky Research Associates Inc.
state: Kentucky
city: Louisville
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facility: L-MARC Research Center
state: Kentucky
city: Lake Charles
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facility: Centex Studies Inc.
state: Louisiana
city: New Orleans
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facility: DelRicht Research
state: Louisiana
city: Shreveport
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facility: Regional Urology LLC
state: Louisiana
city: Hanover
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facility: Chesapeake Urology Research Associates
state: Maryland
city: Boston
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facility: Boston Clinical Trials
state: Massachusetts
city: New Bedford
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facility: BTC of New Bedford
state: Massachusetts
city: North Attleboro
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facility: Regeneris Medical
state: Massachusetts
city: North Dartmouth
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facility: Infinity Medical Research Inc.
state: Massachusetts
city: Quincy
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facility: Beacon Clinical Research
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city: Watertown
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state: Massachusetts
city: Rochester
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state: Michigan
city: Saginaw
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facility: Saginaw Valley Medical Research
state: Michigan
city: Sartell
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city: Poplar Bluff
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facility: Poplar Bluff Urology
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city: Billings
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state: Montana
city: Missoula
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city: Bellevue
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state: Nebraska
city: La Vista
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state: Nebraska
city: Lincoln
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facility: Women's Clinic of Lincoln PC
state: Nebraska
city: Norfolk
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facility: Meridian Clinical Research LLC
state: Nebraska
city: Omaha
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facility: Adult and Pediatric Urology P.C.
state: Nebraska
city: Omaha
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state: Nebraska
city: Las Vegas
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city: Las Vegas
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city: Las Vegas
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facility: Sheldon Freedman MD Ltd
state: Nevada
city: Berlin
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state: New Jersey
city: Edison
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state: New Jersey
city: Englewood
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facility: Urologic Research and Consulting LLC
state: New Jersey
city: Lawrenceville
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facility: Lawrence OB-GYN Clinical Research LLC
state: New Jersey
city: Albuquerque
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facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Albuquerque
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facility: AccumetRx Clinical Research - Division of Urology Group of New Mexico
state: New Mexico
city: Binghamton
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facility: United Medical Associates
state: New York
city: Endwell
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facility: Regional Clinical Research Inc.
state: New York
city: Garden City
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facility: AccuMed Research Associates
state: New York
city: Hartsdale
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facility: Drug Trials America
state: New York
city: Jackson Heights
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facility: Smart Medical Research Inc.
state: New York
city: Port Jefferson
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facility: ProHealth Care AssociatesLLP
state: New York
city: Rochester
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facility: Rochester Clinical Research Inc.
state: New York
city: Williamsville
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facility: Upstate Clinical Research Associates LLC
state: New York
city: Cary
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facility: PMG Research of Cary
state: North Carolina
city: Charlotte
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facility: PMG Research of Charlotte LLC
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research
state: North Carolina
city: Raleigh
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facility: Raleigh Medical Group PMG Research of Raleigh
state: North Carolina
city: Raleigh
country: United States
facility: Associated Urologists of North Carolina
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research of Wilmington, LLC
state: North Carolina
city: Wilmington
country: United States
facility: PMG Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Carolina Medical Trials LLC
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston-Salem
state: North Carolina
city: Cincinnati
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facility: Sentral Clinical Research Services
state: Ohio
city: Cleveland
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facility: Rapid Medical Research
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city: Columbus
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facility: Buckeye Health and Research
state: Ohio
city: Columbus
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facility: Aventiv Research, Inc.
state: Ohio
city: Dayton
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facility: Providence Health Partners
state: Ohio
city: Englewood
country: United States
facility: HWC Womens Research Center
state: Ohio
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions
state: Ohio
city: Wadsworth
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facility: Family Practice Center of Wadsworth Inc. - New Venture Medical Research
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city: Willoughby Hills
country: United States
facility: Ohio Clinical Research LLC
state: Ohio
city: Oklahoma City
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facility: Lynn Health Science Institute
state: Oklahoma
city: Indiana
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facility: Leonard Maliver MD Antria, Inc.
state: Pennsylvania
city: Jenkintown
country: United States
facility: The Clinical Trial Center LLC
state: Pennsylvania
city: Lansdale
country: United States
facility: Green and Seidner Family Practice Associates P.C.
state: Pennsylvania
city: Philadelphia
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facility: Clinical Research of Philadelphia LLC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians Inc.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians Inc.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Research Protocol Management Specialists Hills ObGyn Associates Inc
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Uniontown
country: United States
facility: Preferred Primary Care Physicians Inc.
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: PEAK Research LLC
state: Pennsylvania
city: East Providence
country: United States
facility: Greater Providence Clinical Research, LLC
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Charleston
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Charleston
country: United States
facility: Pharmacorp Clinical Trials Inc.
state: South Carolina
city: Fort Mill
country: United States
facility: Piedmont Research Partners
state: South Carolina
city: Greer
country: United States
facility: DeGarmo Institute of Medical Research
state: South Carolina
city: Moncks Corner
country: United States
facility: PMG Research of Charleston LLC
state: South Carolina
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Mount Pleasant
country: United States
facility: PMG Research of Charleston LLC
state: South Carolina
city: Myrtle Beach
country: United States
facility: Family Medicine of SayeBrook LLC
state: South Carolina
city: Pelzer
country: United States
facility: Palmetto Institute of Clinical Research Inc.
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research LLC
state: South Carolina
city: Summerville
country: United States
facility: Palmetto Clinical Research
state: South Carolina
city: Bristol
country: United States
facility: PMG Research of Bristol LLC
state: Tennessee
city: Chattanooga
country: United States
facility: WR - ClinSearch LLC
state: Tennessee
city: Jackson
country: United States
facility: The Jackson Clinic
state: Tennessee
city: Johnson City
country: United States
facility: MultiSpecialty Clinical Research, Inc.
state: Tennessee
city: Knoxville
country: United States
facility: Volunteer Research Group - NOCCR
state: Tennessee
city: Memphis
country: United States
facility: Adams Patterson Gynecology and Obstetrics
state: Tennessee
city: Nashville
country: United States
facility: Clinical Research Associates Inc.
state: Tennessee
city: Bryan
country: United States
facility: DiscoveResearch Inc.
state: Texas
city: DeSoto
country: United States
facility: WR Global Medical Research
state: Texas
city: Houston
country: United States
facility: Advances in Health
state: Texas
city: Houston
country: United States
facility: Centex Studies Inc.
state: Texas
city: Houston
country: United States
facility: Discovery MM Services Inc.
state: Texas
city: Houston
country: United States
facility: BI Research Center
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions
state: Texas
city: Hurst
country: United States
facility: Protenium Clinical Research
state: Texas
city: Katy
country: United States
facility: Discovery MM Services Inc.
state: Texas
city: Missouri City
country: United States
facility: Discovery MM Services Inc.
state: Texas
city: Plano
country: United States
facility: Village Health Partners ACRC Trials
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas Inc.
state: Texas
city: San Antonio
country: United States
facility: Bandera Family Health Care
state: Texas
city: Spring
country: United States
facility: Clinova Clinical Trials
state: Texas
city: Bountiful
country: United States
facility: Progressive Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: Wasatch Clinical Research LLC
state: Utah
city: West Jordan
country: United States
facility: Advanced Clinical Research
state: Utah
city: Arlington
country: United States
facility: Millennium Clinical Trials
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads Inc.
state: Virginia
city: Burien
country: United States
facility: Seattle Urology Research
state: Washington
city: Seattle
country: United States
facility: Seattle Women's: Health, Research, Gynecology
state: Washington
city: Spokane
country: United States
facility: North Spokane Womens Health
state: Washington
city: Red Deer
country: Canada
facility: Central Alberta Research Clinic
state: Alberta
city: Victoria
country: Canada
facility: Silverado Research Inc.
state: British Columbia
city: Toronto
country: Canada
facility: PrimeHealth Clinical Research
state: Ontario
city: Levis
country: Canada
facility: Manna Research (Quebec)
state: Quebec
city: Montreal
country: Canada
facility: Recherche GCP Research
state: Quebec
city: Montréal
country: Canada
facility: Manna Research (Montreal)
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Csongrád
country: Hungary
facility: Szarka Ödön Egyesitett Egeszsegügyi es Szocialis Intezmeny
city: Debrecen
country: Hungary
facility: Szent Anna Private Surgery
city: Kecskemét
country: Hungary
facility: Mediroyal Prevention Center
city: Pécs
country: Hungary
facility: Uro-clin Ltd
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Riga
country: Latvia
facility: Uro Ltd.
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Klaipėda
country: Lithuania
facility: Public Institution Republican Klaipda Hospital
city: Vilnius
country: Lithuania
facility: Vilnius
city: Vilnius
country: Lithuania
facility: Vilnius city Clinical hospital
city: Wrocław
country: Poland
facility: Poradnia Urologiczna EuroMediCare Szpital Specjalistyczny z Przychodnia
state: Woj. Dolnoslaskie
city: Łódź
country: Poland
facility: ETG Lodz
state: Woj. Lodzkie
city: Lublin
country: Poland
facility: NZOZ NOVITA Specjalistyczne Gabinety Lekarskie
state: Woj. Lubelskie
city: Piaseczno
country: Poland
facility: Nzoz Heureka
state: Woj. Mazowieckie
city: Białystok
country: Poland
facility: Klimed Marek Klimkiewicz
state: Woj. Podlaskie
city: Mysłowice
country: Poland
facility: NZOZ Centrum Urologiczne sp. z o.o.
state: Woj. Slaskie
Study officials:
References:
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citation: Frankel J, Staskin D, Varano S, Kennelly M, Newman DK, Rosenberg MT, Jankowich RA, Shortino D, Mudd PN Jr, Girman CJ. Interpretation of the Meaningfulness of Symptom Reduction with Vibegron in Patients with Overactive Bladder: Analyses from EMPOWUR. Adv Ther. 2022 Feb;39(2):959-970. doi: 10.1007/s12325-021-01972-8. Epub 2021 Dec 18.
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