Clinical trial NCT03475706: Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women
Official title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Oral Solabegron Immediate Release Tablets in the Treatment of Overactive Bladder (OAB) in Adult Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: overactive bladder
urinary conditions
urgency urinary incontinence
urgency
micturitions
Lead sponsor: Velicept Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-23
Enrollment: 438
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Eligible female subjects (N=406) with symptoms of overactive bladder for at least 6 months will enter a 14-day single-blind Run-in Period. Subjects (N=375) who meet prespecified criteria based on data entered into an electronic diary over 3 days will be randomized 1:1:1 (125 subjects per arm) to receive solabegron immediate release tablets, low dose or high dose, or matching placebo.
Primary purpose: TREATMENT

Brief summary: This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of solabegron immediate release low dose or high dose tablets, compared to matched placebo, administered twice daily for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency, and predominantly urgency incontinence) for at least 6 months.


Eligibility criteria: Inclusion Criteria:

* Adult female subjects 18 to 80 years of age, with a ≥ 6-month history of symptoms of overactive bladder including: frequency, urgency, and urgency urinary incontinence. Subjects must provide written informed consent and either be of non-childbearing potential or of childbearing potential meeting specific criteria (e.g., negative pregnancy test, sexual inactivity, acceptable methods of birth control, and use of hormonal contraceptives).

Exclusion Criteria:

* Subjects must have no history of pelvic or bladder disease, e.g., Grade 3/4 uterine prolapse, urogenital malignancy within the past 2 years, surgery for stress incontinence or pelvic prolapse repair within the past 6 months, or bladder injections with botulinum toxin at any time.
* Diabetes insipidus or poorly controlled Type 1 or Type 2 diabetes mellitus
* Cardiac conditions: prior cardiovascular events or procedures within 6 months of screening; congestive heart failure; abnormal ECG findings, including ECG QT correction interval (QTc) \> 470 msec at the Screening Visit; systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥100mmHg, or heart rate \> 100 beats per minute.
* Abnormal tests of liver function
* History of prior infection due to HIV or hepatitis B or hepatitis C virus
* Allergy or hypersensitivity to solabegron or mirabegron
* Women of childbearing potential: breastfeeding, pregnant, or actively trying to become pregnant
* Participation in a trial of an investigational or marketed drug ≤ 30 days prior to the Screening Visit or in any clinical trial of an investigational drug that may affect urinary function within 3 months prior to Screening Visit.
* Inability to read, understand, or complete study-related materials.

Primary outcomes:
measure: Change from Baseline in mean number of micturitions per 24h at Week 12
timeFrame: Micturitions will be assessed prior to randomization and at Week 12 (Visit 6).
Secondary outcomes:
measure: Urinary Incontinence (1)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Urinary Incontinence (2)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4 and 8
measure: Urinary Incontinence (3)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Urinary Incontinence (4)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Urinary Incontinence (5)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Micturitions (1)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4 and 8
measure: Micturitions (2)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Micturitions (3)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Micturitions (4)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Urine Void Volume (1)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Urine Void Volume (2)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Urine Void Volume (3)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Urine Void Volume (4)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Urgency (1)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Urgency (2)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Patient Reported Outcomes (1)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Patient Reported Outcomes (2)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
measure: Patient Reported Outcomes (3)
timeFrame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Velicept Investigative Site - Birmingham
state: Alabama
city: Gulf Shores
country: United States
facility: Velicept Investigative Site - Gulf Shores
state: Alabama
city: Mobile
country: United States
facility: Velicept Investigative Site - Mobile
state: Alabama
city: Tempe
country: United States
facility: Velicept Investigative Site - Tempe
state: Arizona
city: Tucson
country: United States
facility: Velicept Investigative Site - Tucson
state: Arizona
city: Little Rock
country: United States
facility: Velicept Investigative Site - Little Rock
state: Arkansas
city: Anaheim
country: United States
facility: Velicept Investigative Site - Anaheim
state: California
city: Arcadia
country: United States
facility: Velicept Investigative Site - Arcadia
state: California
city: Canoga Park
country: United States
facility: Velicept Investigative Site - Canoga Park
state: California
city: Huntington Beach
country: United States
facility: Velicept Investigative Site - Huntington Beach
state: California
city: Los Alamitos
country: United States
facility: Velicept Investigative Site - Los Alamitos
state: California
city: Los Angeles
country: United States
facility: Velicept Investigative Site - Los Angeles
state: California
city: Norco
country: United States
facility: Velicept Investigative Site - Norco
state: California
city: Sacramento
country: United States
facility: Velicept Investigative Site - Sacramento
state: California
city: San Diego
country: United States
facility: Velicept Investigative Site - San Diego
state: California
city: San Diego
country: United States
facility: Velicept Investigative Site - San Diego
state: California
city: San Marcos
country: United States
facility: Velicept Investigative Site - San Marcos
state: California
city: Thousand Oaks
country: United States
facility: Velicept Investigative Site - Thousand Oaks
state: California
city: Denver
country: United States
facility: Velicept Investigative Site - Denver
state: Colorado
city: Waterbury
country: United States
facility: Velicept Investigative Site - Waterbury
state: Connecticut
city: Clearwater
country: United States
facility: Velicept Investigative Site - Clearwater
state: Florida
city: DeLand
country: United States
facility: Velicept Investigative Site - Deland
state: Florida
city: Doral
country: United States
facility: Velicept Investigative Site - Doral
state: Florida
city: Jupiter
country: United States
facility: Velicept Investigative Site - Jupiter
state: Florida
city: Lake City
country: United States
facility: Velicept Investigative Site - Lake City
state: Florida
city: Miami
country: United States
facility: Velicept Investigative Site - Miami
state: Florida
city: Miami
country: United States
facility: Velicept Investigative Site - Miami
state: Florida
city: Miami
country: United States
facility: Velicept Investigative Site - Miami
state: Florida
city: Ponte Vedra
country: United States
facility: Velicept Investigative Site - Ponte Vedra
state: Florida
city: Port Saint Lucie
country: United States
facility: Velicept Investigative Site - Port St Lucie
state: Florida
city: West Palm Beach
country: United States
facility: Velicept Investigative Site - West Palm Beach
state: Florida
city: Winter Haven
country: United States
facility: Velicept Investigative Site - Winter Haven
state: Florida
city: Marietta
country: United States
facility: Velicept Investigative Site - Marietta
state: Georgia
city: Blackfoot
country: United States
facility: Velicept Investigative Site - Blackfoot
state: Idaho
city: Meridian
country: United States
facility: Velicept Investigative Site - Meridian
state: Idaho
city: Wauconda
country: United States
facility: Velicept Investigative Site - Wauconda
state: Illinois
city: Elwood
country: United States
facility: Velicept Investigative Site - Elwood
state: Indiana
city: Evansville
country: United States
facility: Velicept Investigative Site - Evansville
state: Indiana
city: Newton
country: United States
facility: Velicept Investigative Site - Newton
state: Kansas
city: Louisville
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facility: Velicept Investigative Site - Louisville
state: Kentucky
city: Metairie
country: United States
facility: Velicept Investigative Site - Metairie
state: Louisiana
city: New Orleans
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facility: Velicept Investigative Site - New Orleans
state: Louisiana
city: Shreveport
country: United States
facility: Velicept Investigative Site - Shreveport
state: Louisiana
city: Boston
country: United States
facility: Velicept Investigative Site - Boston
state: Massachusetts
city: New Bedford
country: United States
facility: Velicept Investigative Site - New Bedford
state: Massachusetts
city: North Attleboro
country: United States
facility: Velicept Investigative Site - North Attleborro
state: Massachusetts
city: Watertown
country: United States
facility: Velicept Investigative Site - Watertown
state: Massachusetts
city: Kalamazoo
country: United States
facility: Velicept Investigative Site - Kalamazoo
state: Michigan
city: Saint Louis
country: United States
facility: Velicept Investigative Site - St. Louis
state: Missouri
city: Omaha
country: United States
facility: Velicept Investigative Site - Omaha
state: Nebraska
city: Las Vegas
country: United States
facility: Velicept Investigative Site - Las Vegas
state: Nevada
city: Brick
country: United States
facility: Velicept Investigative Site - Brick
state: New Jersey
city: Voorhees
country: United States
facility: Velicept Investigative Site - Vorhees
state: New Jersey
city: Albuquerque
country: United States
facility: Velicept Investigative Site - Albuquerque
state: New Mexico
city: New York
country: United States
facility: Velicept Investigative Site - New York
state: New York
city: Williamsville
country: United States
facility: Velicept Investigative Site - Williamsville
state: New York
city: Charlotte
country: United States
facility: Velicept Investigative Site - Charlotte
state: North Carolina
city: Wilmington
country: United States
facility: Velicept Investigative Site - Wilmington
state: North Carolina
city: Winston-Salem
country: United States
facility: Velicept Investigative Site - Winston-Salem
state: North Carolina
city: Cincinnati
country: United States
facility: Velicept Investigative Site - Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: Velicept Investigative Site - Cleveland
state: Ohio
city: Columbus
country: United States
facility: Velicept Investigative Site - Columbus
state: Ohio
city: Marion
country: United States
facility: Velicept Investigative Site - Marion
state: Ohio
city: Middleburg Heights
country: United States
facility: Velicept Investigative Site - Middleburg Heights
state: Ohio
city: Warwick
country: United States
facility: Velicept Investigative Site - Warwick
state: Rhode Island
city: Mount Pleasant
country: United States
facility: Velicept Investigative Site - Mt. Pleasant
state: South Carolina
city: Myrtle Beach
country: United States
facility: Velicept Investigative Site - Myrtle Beach
state: South Carolina
city: Jackson
country: United States
facility: Velicept Investigative Site - Jackson
state: Tennessee
city: Knoxville
country: United States
facility: Velicept Investigative Site - Knoxville
state: Tennessee
city: Nashville
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facility: Velicept Investigative Site - Nashville
state: Tennessee
city: Austin
country: United States
facility: Velicept Investigative Site - Austin
state: Texas
city: Beaumont
country: United States
facility: Velicept Investigative Site - Beaumont
state: Texas
city: Lampasas
country: United States
facility: Velicept Investigative Site - Lampasas
state: Texas
city: Longview
country: United States
facility: Velicept Investigative Site - Longview
state: Texas
city: San Antonio
country: United States
facility: Velicept Investigative Site - San Antonio
state: Texas
city: San Antonio
country: United States
facility: Velicept Investigative Site - San Antonio
state: Texas
city: San Antonio
country: United States
facility: Velicept Investigative Site - San Antonio
state: Texas
city: Clinton
country: United States
facility: Velicept Investigative Site - Clinton
state: Utah
city: Saint George
country: United States
facility: Velicept Investigative Site - St. George
state: Utah
city: Salt Lake City
country: United States
facility: Velicept Investigative Site - Salt Lake City
state: Utah
city: Salt Lake City
country: United States
facility: Velicept Investigative Site - Salt Lake City
state: Utah
city: West Jordan
country: United States
facility: Velicept Investigative Site - West Jordan
state: Utah
city: Newport News
country: United States
facility: Velicept Investigative Site - Newport News
state: Virginia
city: Norfolk
country: United States
facility: Velicept Investigative Site - Norfolk
state: Virginia
city: Tacoma
country: United States
facility: Velicept Investigative Site - Tacoma
state: Washington
city: Kenosha
country: United States
facility: Velicept Investigative Site - Kenosha
state: Wisconsin
Study officials:
References:
citation: Ohlstein EH, von Keitz A, Michel MC. A multicenter, double-blind, randomized, placebo-controlled trial of the beta3-adrenoceptor agonist solabegron for overactive bladder. Eur Urol. 2012 Nov;62(5):834-40. doi: 10.1016/j.eururo.2012.05.053. Epub 2012 Jun 5.