Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women
- Conditions
- Overactive Bladder
- Interventions
- Registration Number
- NCT03475706
- Lead Sponsor
- Velicept Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 438
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Comparator Matching Placebo - Solabegron immediate release tablets low dose Solabegron immediate release tablets, low dose - Solabegron immediate release tablets high dose Solabegron immediate release tablets, high dose -
- Primary Outcome Measures
Name Time Method Change from Baseline in mean number of micturitions per 24h at Week 12 Micturitions will be assessed prior to randomization and at Week 12 (Visit 6). Micturition events will be recorded by subjects in an eDiary using a smartphone device during 3-day diary periods prior to randomization and at 12 weeks.
- Secondary Outcome Measures
Name Time Method Urinary Incontinence (5) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Change from Baseline in total urinary incontinence episodes (urgency and non-urgency) per 24h.
Micturitions (1) Prior to Randomization (Baseline) and at Weeks 4 and 8 Change from Baseline in mean number of micturitions per 24h.
Micturitions (4) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Change from Baseline in mean number of nocturnal voids per 24h.
Urine Void Volume (1) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Change from Baseline in average void volume over 24h.
Urine Void Volume (2) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Percentage change from Baseline in average void volume over 24h.
Urine Void Volume (3) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Change from Baseline in maximum individual void volume over 24h.
Urine Void Volume (4) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Percentage change from Baseline in maximum individual void volume over 24h.
Urgency (1) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Proportion of subjects with urges with a mean grade of 3 or 4 per 24h.
Urgency (2) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Change from Baseline in urgency assessments per 24h associated with micturitions and incontinence.
Patient Reported Outcomes (1) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Patient Perception of Bladder Condition
Patient Reported Outcomes (2) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Change from Baseline in Symptom Bother Score (OAB-q short form).
Urinary Incontinence (1) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Change from Baseline in mean number of urgency urinary incontinence episodes per 24h.
Micturitions (3) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Percentage of subjects with \<8 micturitions per 24h.
Urinary Incontinence (4) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Proportion of subjects with no episodes of urinary incontinence (urgency or non-urgency) per 24h.
Urinary Incontinence (2) Prior to Randomization (Baseline) and at Weeks 4 and 8 Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24h.
Micturitions (2) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Percentage change from Baseline in mean number of micturitions per 24h.
Urinary Incontinence (3) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Proportion of subjects with no episodes of urgency urinary incontinence per 24h.
Patient Reported Outcomes (3) Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 Change from Baseline in health-related quality of life (OAB-q short form).
Trial Locations
- Locations (80)
Velicept Investigative Site - Kalamazoo
🇺🇸Kalamazoo, Michigan, United States
Velicept Investigative Site - Los Angeles
🇺🇸Los Angeles, California, United States
Velicept Investigative Site - Boston
🇺🇸Boston, Massachusetts, United States
Velicept Investigative Site - Arcadia
🇺🇸Arcadia, California, United States
Velicept Investigative Site - Blackfoot
🇺🇸Blackfoot, Idaho, United States
Velicept Investigative Site - Tempe
🇺🇸Tempe, Arizona, United States
Velicept Investigative Site - Thousand Oaks
🇺🇸Thousand Oaks, California, United States
Velicept Investigative Site - Doral
🇺🇸Doral, Florida, United States
Velicept Investigative Site - Ponte Vedra
🇺🇸Ponte Vedra, Florida, United States
Velicept Investigative Site - Mobile
🇺🇸Mobile, Alabama, United States
Velicept Investigative Site - Miami
🇺🇸Miami, Florida, United States
Velicept Investigative Site - Wauconda
🇺🇸Wauconda, Illinois, United States
Velicept Investigative Site - Sacramento
🇺🇸Sacramento, California, United States
Velicept Investigative Site - Gulf Shores
🇺🇸Gulf Shores, Alabama, United States
Velicept Investigative Site - Waterbury
🇺🇸Waterbury, Connecticut, United States
Velicept Investigative Site - Anaheim
🇺🇸Anaheim, California, United States
Velicept Investigative Site - Clearwater
🇺🇸Clearwater, Florida, United States
Velicept Investigative Site - San Marcos
🇺🇸San Marcos, California, United States
Velicept Investigative Site - Columbus
🇺🇸Columbus, Ohio, United States
Velicept Investigative Site - Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Velicept Investigative Site - Winter Haven
🇺🇸Winter Haven, Florida, United States
Velicept Investigative Site - Meridian
🇺🇸Meridian, Idaho, United States
Velicept Investigative Site - Watertown
🇺🇸Watertown, Massachusetts, United States
Velicept Investigative Site - Beaumont
🇺🇸Beaumont, Texas, United States
Velicept Investigative Site - Clinton
🇺🇸Clinton, Utah, United States
Velicept Investigative Site - Knoxville
🇺🇸Knoxville, Tennessee, United States
Velicept Investigative Site - Newport News
🇺🇸Newport News, Virginia, United States
Velicept Investigative Site - Elwood
🇺🇸Elwood, Indiana, United States
Velicept Investigative Site - New York
🇺🇸New York, New York, United States
Velicept Investigative Site - West Jordan
🇺🇸West Jordan, Utah, United States
Velicept Investigative Site - Marion
🇺🇸Marion, Ohio, United States
Velicept Investigative Site - Middleburg Heights
🇺🇸Middleburg Heights, Ohio, United States
Velicept Investigative Site - Warwick
🇺🇸Warwick, Rhode Island, United States
Velicept Investigative Site - Cleveland
🇺🇸Cleveland, Ohio, United States
Velicept Investigative Site - Williamsville
🇺🇸Williamsville, New York, United States
Velicept Investigative Site - Wilmington
🇺🇸Wilmington, North Carolina, United States
Velicept Investigative Site - Myrtle Beach
🇺🇸Myrtle Beach, South Carolina, United States
Velicept Investigative Site - Brick
🇺🇸Brick, New Jersey, United States
Velicept Investigative Site - Newton
🇺🇸Newton, Kansas, United States
Velicept Investigative Site - Birmingham
🇺🇸Birmingham, Alabama, United States
Velicept Investigative Site - Las Vegas
🇺🇸Las Vegas, Nevada, United States
Velicept Investigative Site - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Velicept Investigative Site - Nashville
🇺🇸Nashville, Tennessee, United States
Velicept Investigative Site - San Antonio
🇺🇸San Antonio, Texas, United States
Velicept Investigative Site - Denver
🇺🇸Denver, Colorado, United States
Velicept Investigative Site - Omaha
🇺🇸Omaha, Nebraska, United States
Velicept Investigative Site - St. George
🇺🇸Saint George, Utah, United States
Velicept Investigative Site - Tucson
🇺🇸Tucson, Arizona, United States
Velicept Investigative Site - Little Rock
🇺🇸Little Rock, Arkansas, United States
Velicept Investigative Site - Los Alamitos
🇺🇸Los Alamitos, California, United States
Velicept Investigative Site - Norco
🇺🇸Norco, California, United States
Velicept Investigative Site - San Diego
🇺🇸San Diego, California, United States
Velicept Investigative Site - Deland
🇺🇸DeLand, Florida, United States
Velicept Investigative Site - Jupiter
🇺🇸Jupiter, Florida, United States
Velicept Investigative Site - Lake City
🇺🇸Lake City, Florida, United States
Velicept Investigative Site - Port St Lucie
🇺🇸Port Saint Lucie, Florida, United States
Velicept Investigative Site - West Palm Beach
🇺🇸West Palm Beach, Florida, United States
Velicept Investigative Site - Marietta
🇺🇸Marietta, Georgia, United States
Velicept Investigative Site - Evansville
🇺🇸Evansville, Indiana, United States
Velicept Investigative Site - Louisville
🇺🇸Louisville, Kentucky, United States
Velicept Investigative Site - New Bedford
🇺🇸New Bedford, Massachusetts, United States
Velicept Investigative Site - Metairie
🇺🇸Metairie, Louisiana, United States
Velicept Investigative Site - Shreveport
🇺🇸Shreveport, Louisiana, United States
Velicept Investigative Site - North Attleborro
🇺🇸North Attleboro, Massachusetts, United States
Velicept Investigative Site - St. Louis
🇺🇸Saint Louis, Missouri, United States
Velicept Investigative Site - Vorhees
🇺🇸Voorhees, New Jersey, United States
Velicept Investigative Site - Albuquerque
🇺🇸Albuquerque, New Mexico, United States
Velicept Investigative Site - Charlotte
🇺🇸Charlotte, North Carolina, United States
Velicept Investigative Site - Austin
🇺🇸Austin, Texas, United States
Velicept Investigative Site - Salt Lake City
🇺🇸Salt Lake City, Utah, United States
Velicept Investigative Site - Kenosha
🇺🇸Kenosha, Wisconsin, United States
Velicept Investigative Site - Canoga Park
🇺🇸Canoga Park, California, United States
Velicept Investigative Site - New Orleans
🇺🇸New Orleans, Louisiana, United States
Velicept Investigative Site - Lampasas
🇺🇸Lampasas, Texas, United States
Velicept Investigative Site - Longview
🇺🇸Longview, Texas, United States
Velicept Investigative Site - Jackson
🇺🇸Jackson, Tennessee, United States
Velicept Investigative Site - Norfolk
🇺🇸Norfolk, Virginia, United States
Velicept Investigative Site - Tacoma
🇺🇸Tacoma, Washington, United States
Velicept Investigative Site - Mt. Pleasant
🇺🇸Mount Pleasant, South Carolina, United States
Velicept Investigative Site - Huntington Beach
🇺🇸Huntington Beach, California, United States