Overactive Bladder Clinical Trial
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
| Verified date | January 2019 |
| Source | Velicept Therapeutics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 438 |
| Est. completion date | January 30, 2019 |
| Est. primary completion date | January 24, 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Velicept Investigative Site - Albuquerque | Albuquerque | New Mexico |
| United States | Velicept Investigative Site - Anaheim | Anaheim | California |
| United States | Velicept Investigative Site - Arcadia | Arcadia | California |
| United States | Velicept Investigative Site - Austin | Austin | Texas |
| United States | Velicept Investigative Site - Beaumont | Beaumont | Texas |
| United States | Velicept Investigative Site - Birmingham | Birmingham | Alabama |
| United States | Velicept Investigative Site - Blackfoot | Blackfoot | Idaho |
| United States | Velicept Investigative Site - Boston | Boston | Massachusetts |
| United States | Velicept Investigative Site - Brick | Brick | New Jersey |
| United States | Velicept Investigative Site - Canoga Park | Canoga Park | California |
| United States | Velicept Investigative Site - Charlotte | Charlotte | North Carolina |
| United States | Velicept Investigative Site - Cincinnati | Cincinnati | Ohio |
| United States | Velicept Investigative Site - Clearwater | Clearwater | Florida |
| United States | Velicept Investigative Site - Cleveland | Cleveland | Ohio |
| United States | Velicept Investigative Site - Clinton | Clinton | Utah |
| United States | Velicept Investigative Site - Columbus | Columbus | Ohio |
| United States | Velicept Investigative Site - Deland | DeLand | Florida |
| United States | Velicept Investigative Site - Denver | Denver | Colorado |
| United States | Velicept Investigative Site - Doral | Doral | Florida |
| United States | Velicept Investigative Site - Elwood | Elwood | Indiana |
| United States | Velicept Investigative Site - Evansville | Evansville | Indiana |
| United States | Velicept Investigative Site - Gulf Shores | Gulf Shores | Alabama |
| United States | Velicept Investigative Site - Huntington Beach | Huntington Beach | California |
| United States | Velicept Investigative Site - Jackson | Jackson | Tennessee |
| United States | Velicept Investigative Site - Jupiter | Jupiter | Florida |
| United States | Velicept Investigative Site - Kalamazoo | Kalamazoo | Michigan |
| United States | Velicept Investigative Site - Kenosha | Kenosha | Wisconsin |
| United States | Velicept Investigative Site - Knoxville | Knoxville | Tennessee |
| United States | Velicept Investigative Site - Lake City | Lake City | Florida |
| United States | Velicept Investigative Site - Lampasas | Lampasas | Texas |
| United States | Velicept Investigative Site - Las Vegas | Las Vegas | Nevada |
| United States | Velicept Investigative Site - Little Rock | Little Rock | Arkansas |
| United States | Velicept Investigative Site - Longview | Longview | Texas |
| United States | Velicept Investigative Site - Los Alamitos | Los Alamitos | California |
| United States | Velicept Investigative Site - Los Angeles | Los Angeles | California |
| United States | Velicept Investigative Site - Louisville | Louisville | Kentucky |
| United States | Velicept Investigative Site - Marietta | Marietta | Georgia |
| United States | Velicept Investigative Site - Marion | Marion | Ohio |
| United States | Velicept Investigative Site - Meridian | Meridian | Idaho |
| United States | Velicept Investigative Site - Metairie | Metairie | Louisiana |
| United States | Velicept Investigative Site - Miami | Miami | Florida |
| United States | Velicept Investigative Site - Miami | Miami | Florida |
| United States | Velicept Investigative Site - Miami | Miami | Florida |
| United States | Velicept Investigative Site - Middleburg Heights | Middleburg Heights | Ohio |
| United States | Velicept Investigative Site - Mobile | Mobile | Alabama |
| United States | Velicept Investigative Site - Mt. Pleasant | Mount Pleasant | South Carolina |
| United States | Velicept Investigative Site - Myrtle Beach | Myrtle Beach | South Carolina |
| United States | Velicept Investigative Site - Nashville | Nashville | Tennessee |
| United States | Velicept Investigative Site - New Bedford | New Bedford | Massachusetts |
| United States | Velicept Investigative Site - New Orleans | New Orleans | Louisiana |
| United States | Velicept Investigative Site - New York | New York | New York |
| United States | Velicept Investigative Site - Newport News | Newport News | Virginia |
| United States | Velicept Investigative Site - Newton | Newton | Kansas |
| United States | Velicept Investigative Site - Norco | Norco | California |
| United States | Velicept Investigative Site - Norfolk | Norfolk | Virginia |
| United States | Velicept Investigative Site - North Attleborro | North Attleboro | Massachusetts |
| United States | Velicept Investigative Site - Omaha | Omaha | Nebraska |
| United States | Velicept Investigative Site - Ponte Vedra | Ponte Vedra | Florida |
| United States | Velicept Investigative Site - Port St Lucie | Port Saint Lucie | Florida |
| United States | Velicept Investigative Site - Sacramento | Sacramento | California |
| United States | Velicept Investigative Site - St. George | Saint George | Utah |
| United States | Velicept Investigative Site - St. Louis | Saint Louis | Missouri |
| United States | Velicept Investigative Site - Salt Lake City | Salt Lake City | Utah |
| United States | Velicept Investigative Site - Salt Lake City | Salt Lake City | Utah |
| United States | Velicept Investigative Site - San Antonio | San Antonio | Texas |
| United States | Velicept Investigative Site - San Antonio | San Antonio | Texas |
| United States | Velicept Investigative Site - San Antonio | San Antonio | Texas |
| United States | Velicept Investigative Site - San Diego | San Diego | California |
| United States | Velicept Investigative Site - San Diego | San Diego | California |
| United States | Velicept Investigative Site - San Marcos | San Marcos | California |
| United States | Velicept Investigative Site - Shreveport | Shreveport | Louisiana |
| United States | Velicept Investigative Site - Tacoma | Tacoma | Washington |
| United States | Velicept Investigative Site - Tempe | Tempe | Arizona |
| United States | Velicept Investigative Site - Thousand Oaks | Thousand Oaks | California |
| United States | Velicept Investigative Site - Tucson | Tucson | Arizona |
| United States | Velicept Investigative Site - Vorhees | Voorhees | New Jersey |
| United States | Velicept Investigative Site - Warwick | Warwick | Rhode Island |
| United States | Velicept Investigative Site - Waterbury | Waterbury | Connecticut |
| United States | Velicept Investigative Site - Watertown | Watertown | Massachusetts |
| United States | Velicept Investigative Site - Wauconda | Wauconda | Illinois |
| United States | Velicept Investigative Site - West Jordan | West Jordan | Utah |
| United States | Velicept Investigative Site - West Palm Beach | West Palm Beach | Florida |
| United States | Velicept Investigative Site - Williamsville | Williamsville | New York |
| United States | Velicept Investigative Site - Wilmington | Wilmington | North Carolina |
| United States | Velicept Investigative Site - Winston-Salem | Winston-Salem | North Carolina |
| United States | Velicept Investigative Site - Winter Haven | Winter Haven | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Velicept Therapeutics, Inc. |
United States,
Ohlstein EH, von Keitz A, Michel MC. A multicenter, double-blind, randomized, placebo-controlled trial of the ß3-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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline in mean number of micturitions per 24h at Week 12 | 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. | Micturitions will be assessed prior to randomization and at Week 12 (Visit 6). | |
| Secondary | Urinary Incontinence (1) | Change from Baseline in mean number of urgency urinary incontinence episodes per 24h. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Urinary Incontinence (2) | Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24h. | Prior to Randomization (Baseline) and at Weeks 4 and 8 | |
| Secondary | Urinary Incontinence (3) | Proportion of subjects with no episodes of urgency urinary incontinence per 24h. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Urinary Incontinence (4) | Proportion of subjects with no episodes of urinary incontinence (urgency or non-urgency) per 24h. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Urinary Incontinence (5) | Change from Baseline in total urinary incontinence episodes (urgency and non-urgency) per 24h. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Micturitions (1) | Change from Baseline in mean number of micturitions per 24h. | Prior to Randomization (Baseline) and at Weeks 4 and 8 | |
| Secondary | Micturitions (2) | Percentage change from Baseline in mean number of micturitions per 24h. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Micturitions (3) | Percentage of subjects with <8 micturitions per 24h. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Micturitions (4) | Change from Baseline in mean number of nocturnal voids per 24h. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Urine Void Volume (1) | Change from Baseline in average void volume over 24h. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Urine Void Volume (2) | Percentage change from Baseline in average void volume over 24h. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Urine Void Volume (3) | Change from Baseline in maximum individual void volume over 24h. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Urine Void Volume (4) | Percentage change from Baseline in maximum individual void volume over 24h. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Urgency (1) | Proportion of subjects with urges with a mean grade of 3 or 4 per 24h. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Urgency (2) | Change from Baseline in urgency assessments per 24h associated with micturitions and incontinence. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Patient Reported Outcomes (1) | Patient Perception of Bladder Condition | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Patient Reported Outcomes (2) | Change from Baseline in Symptom Bother Score (OAB-q short form). | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | Patient Reported Outcomes (3) | Change from Baseline in health-related quality of life (OAB-q short form). | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
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