Clinical trial NCT03594058: A Study to Evaluate Once Daily Low Dose and High Dose Solabegron or Placebo Given for 12 Weeks to Treat Women With Symptoms of Overactive Bladder: Sudden Urge to Urinate, Frequent Urination Associated With Wetting Episodes (VEL-2001)
Official title: A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Oral Solabegron Modified 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: 2018-07-20
Enrollment: 1413
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=1200) 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 modified 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 modified release low dose or high dose tablets, compared to matched placebo, administered once 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, urgency urinary incontinence, and mixed 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., uterine prolapse, malignancy, prior surgery, or treatment with botulinum toxin.
* 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 ≥ 100 mmHg, 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 24 hours at Week 12
timeFrame: Micturtions 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, 8, and 12
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: Birmingham
country: United States
facility: Velicept Investigative Site - Birmingham
state: Alabama
city: Guntersville
country: United States
facility: Velicept Investigative Site - Guntersville
state: Alabama
city: Saraland
country: United States
facility: Velicept Investigative Site - Saraland
state: Alabama
city: Tucson
country: United States
facility: Velicept Investigative Site - Tucson
state: Arizona
city: Tucson
country: United States
facility: Velicept Investigative Site - Tucson
state: Arizona
city: Lincoln
country: United States
facility: Velicept Investigative Site - Lincoln
state: California
city: North Hollywood
country: United States
facility: Velicept Investigative Site - North Hollywood
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: Spring Valley
country: United States
facility: Velicept Investigative Site - Spring Valley
state: California
city: Upland
country: United States
facility: Velicept Investigative Site - Upland
state: California
city: Aurora
country: United States
facility: Velicept Investigative Site - Aurora
state: Colorado
city: Englewood
country: United States
facility: Velicept Investigative Site - Englewood
state: Colorado
city: New London
country: United States
facility: Velicept Investigative Site - New London
state: Connecticut
city: Aventura
country: United States
facility: Velicept Investigative Site - Aventura
state: Florida
city: Doral
country: United States
facility: Velicept Investigative Site - Doral(2)
state: Florida
city: Doral
country: United States
facility: Velicept Investigative Site - Doral
state: Florida
city: Edgewater
country: United States
facility: Velicept Investigative Site - Edgewater
state: Florida
city: Hialeah
country: United States
facility: Velicept Investigative Site - Hialeah
state: Florida
city: Hollywood
country: United States
facility: Velicept Investigative Site - Hollywood
state: Florida
city: Lauderdale Lakes
country: United States
facility: Velicept Investigative Site - Lauderdale Lakes
state: Florida
city: Miami Springs
country: United States
facility: Velicept Investigative Site - Miami Springs
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: New Port Richey
country: United States
facility: Velicept Investigative Site - New Port Richey
state: Florida
city: Palm Harbor
country: United States
facility: Velicept Investigative Site - Palm Harbor
state: Florida
city: Pompano Beach
country: United States
facility: Velicept Investigative Site - Pompano Beach
state: Florida
city: Tampa
country: United States
facility: Velicept Investigative Site - Tampa
state: Florida
city: West Palm Beach
country: United States
facility: Velicept Investigative Site - West Palm Beach
state: Florida
city: Atlanta
country: United States
facility: Velicept Investigative Site - Atlanta
state: Georgia
city: Snellville
country: United States
facility: Velicept Investigative Site - Snellville
state: Georgia
city: Crowley
country: United States
facility: Velicept Investigative Site - Crowley
state: Louisiana
city: Metairie
country: United States
facility: Velicept Investigative Site - Metairie
state: Louisiana
city: Brighton
country: United States
facility: Velicept Investigative Site - Brighton
state: Massachusetts
city: North Dartmouth
country: United States
facility: Velicept Investigative Site - North Dartmouth
state: Massachusetts
city: Saginaw
country: United States
facility: Velicept Investigative Site - Saginaw
state: Michigan
city: Biloxi
country: United States
facility: Velicept Investigative Site - Biloxi
state: Mississippi
city: Olive Branch
country: United States
facility: Velicept Investigative Site - Olive Branch
state: Mississippi
city: La Vista
country: United States
facility: Velicept Investigative Site - La Vista
state: Nebraska
city: Las Vegas
country: United States
facility: Velicept Investigative Site - Las Vegas
state: Nevada
city: Las Vegas
country: United States
facility: Velicept Investigative Site - Las Vegas
state: Nevada
city: Las Vegas
country: United States
facility: Velicept Investigative Site - Las Vegas
state: Nevada
city: Edison
country: United States
facility: Velicept Investigative Site - Edison
state: New Jersey
city: Raleigh
country: United States
facility: Velicept Investigative Site - Raleigh
state: North Carolina
city: Fargo
country: United States
facility: Velicept Investigative Site - Fargo
state: North Dakota
city: Dayton
country: United States
facility: Velicept Investigative Site - Dayton
state: Ohio
city: Mustang
country: United States
facility: Velicept Investigative Site - Mustang
state: Oklahoma
city: Oklahoma City
country: United States
facility: Velicept Investigative Site - Oklahoma City
state: Oklahoma
city: Gresham
country: United States
facility: Velicept Investigative Site - Gresham
state: Oregon
city: Lansdale
country: United States
facility: Velicept Investigative Site - Lansdale
state: Pennsylvania
city: East Providence
country: United States
facility: Velicept Investigative Site - East Providence
state: Rhode Island
city: Lincoln
country: United States
facility: Velicept Investigative Site - Lincoln
state: Rhode Island
city: Charleston
country: United States
facility: Velicept Investigative Site - Charleston
state: South Carolina
city: Charleston
country: United States
facility: Velicept Investigative Site - Charleston
state: South Carolina
city: Fort Mill
country: United States
facility: Velicept Investigative Site - Fort Mill
state: South Carolina
city: Spartanburg
country: United States
facility: Velicept Investigative Site - Spartanburg
state: South Carolina
city: Chattanooga
country: United States
facility: Velicept Investigative Site - Chattanooga
state: Tennessee
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: Austin
country: United States
facility: Velicept Investigative Site - Austin
state: Texas
city: Austin
country: United States
facility: Velicept Investigative Site - Austin
state: Texas
city: Bryan
country: United States
facility: Velicept Investigative Site - Bryan
state: Texas
city: Carrollton
country: United States
facility: Velicept Investigative Site - Carrollton
state: Texas
city: Dallas
country: United States
facility: Velicept Investigative Site - Dallas
state: Texas
city: Fort Worth
country: United States
facility: Velicept Investigative Site - Fort Worth
state: Texas
city: Georgetown
country: United States
facility: Velicept Investigative Site - Georgetown
state: Texas
city: Houston
country: United States
facility: Velicept Investigative Site - Houston
state: Texas
city: Houston
country: United States
facility: Velicept Investigative Site - Houston
state: Texas
city: Plano
country: United States
facility: Velicept Investigative Site - Plano(1)
state: Texas
city: Plano
country: United States
facility: Velicept Investigative Site - Plano(2)
state: Texas
city: San Angelo
country: United States
facility: Velicept Investigative Site - San Angelo
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: Sugar Land
country: United States
facility: Velicept Investigative Site - Sugar Land
state: Texas
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.