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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solabegron modified release tablets low dose | Experimental |
| |
| Solabegron modified release tablets high dose | Experimental |
| |
| Placebo Comparator | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solabegron modified release tablets, low dose | Drug | Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in mean number of micturitions per 24 hours 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. | Micturtions will be assessed prior to randomization and at Week 12 (Visit 6). |
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Incontinence (1) | Change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Urinary Incontinence (2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velicept Investigative Site - Birmingham | Birmingham | Alabama | 35209 | United States | ||
| Velicept Investigative Site - Birmingham |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22695239 | Background | 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. |
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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.
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Sponsor representatives Site monitors Data managers Statistician
| Solabegron modified release tablets, high dose | Drug | Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks. |
|
| Matching Placebo | Drug | Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks. |
|
Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours
| Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Urinary Incontinence (3) | Proportion of subjects with no episodes of urgency urinary incontinence per 24 hours | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Urinary Incontinence (4) | Proportion of subjects with no episodes of urinary incontinence (urgency and non-urgency) per 24 hours | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Urinary Incontinence (5) | Change from Baseline in total urinary incontinence episodes (urgency and non-urgency) per 24 hours | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Micturitions (1) | Change from Baseline in mean number of micturitions per 24 hours | Prior to Randomization (Baseline) and at Weeks 4 and 8 |
| Micturitions (2) | Percentage change from Baseline in mean number of micturitions per 24 hours | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Micturitions (3) | Percentage of subjects with < 8 micturitions per 24 hours | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Micturitions (4) | Change from Baseline in mean number of nocturnal voids per 24 hours | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Urine Void Volume (1) | Change from Baseline in average void volume over 24 hours | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Urine Void Volume (2) | Percentage change from Baseline in average void volume over 24 hours | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Urine Void Volume (3) | Change from Baseline in maximum individual void volume over 24 hours | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Urine Void Volume (4) | Percentage change from Baseline in maximum individual void volume over 24 hours | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Urgency (1) | Proportion of subjects with urges with a mean grade of 3 of 4 per 24 hours | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Urgency (2) | Change from Baseline in mean urgency assessments per 24 hours associated with micturitions or incontinence | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Patient Reported Outcomes (1) | Patient Perception of Bladder Control. This patient-reported questionnaire assesses the patient's perception of current urinary problems, where higher score (on a scale of 1 to 6) indicates more severe problems. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Patient Reported Outcomes (2) | Change from Baseline in Symptom Bother Score (Overactive Bladder Questionnaire [OAB-q] short form). The OAB-q short form is completed as a 4-week recall where a higher score (on a scale of 1 to 6) indicates greater symptoms. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Patient Reported Outcomes (3) | Change from Baseline in health-related quality of life (Overactive Bladder Questionnaire [OAB-q] short form). The OAB-q short form is completed as a 4-week recall where a higher score (on a scale of 1 to 6) indicates worse health-related quality of life. | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 |
| Birmingham |
| Alabama |
| 35215 |
| United States |
| Velicept Investigative Site - Guntersville | Guntersville | Alabama | 35976 | United States |
| Velicept Investigative Site - Saraland | Saraland | Alabama | 36571 | United States |
| Velicept Investigative Site - Tucson | Tucson | Arizona | 85741 | United States |
| Velicept Investigative Site - Tucson | Tucson | Arizona | 85745 | United States |
| Velicept Investigative Site - Lincoln | Lincoln | California | 95648 | United States |
| Velicept Investigative Site - North Hollywood | North Hollywood | California | 91606 | United States |
| Velicept Investigative Site - Sacramento | Sacramento | California | 95864 | United States |
| Velicept Investigative Site - San Diego | San Diego | California | 92108 | United States |
| Velicept Investigative Site - San Diego | San Diego | California | 92111 | United States |
| Velicept Investigative Site - Spring Valley | Spring Valley | California | 91978 | United States |
| Velicept Investigative Site - Upland | Upland | California | 91786 | United States |
| Velicept Investigative Site - Aurora | Aurora | Colorado | 80012 | United States |
| Velicept Investigative Site - Englewood | Englewood | Colorado | 80113 | United States |
| Velicept Investigative Site - New London | New London | Connecticut | 06320 | United States |
| Velicept Investigative Site - Aventura | Aventura | Florida | 33180 | United States |
| Velicept Investigative Site - Doral(2) | Doral | Florida | 33166 | United States |
| Velicept Investigative Site - Doral | Doral | Florida | 33166 | United States |
| Velicept Investigative Site - Edgewater | Edgewater | Florida | 32132 | United States |
| Velicept Investigative Site - Hialeah | Hialeah | Florida | 33012 | United States |
| Velicept Investigative Site - Hollywood | Hollywood | Florida | 33024 | United States |
| Velicept Investigative Site - Lauderdale Lakes | Lauderdale Lakes | Florida | 33319 | United States |
| Velicept Investigative Site - Miami | Miami | Florida | 33015 | United States |
| Velicept Investigative Site - Miami | Miami | Florida | 33144 | United States |
| Velicept Investigative Site - Miami | Miami | Florida | 33155 | United States |
| Velicept Investigative Site - Miami Springs | Miami Springs | Florida | 33166 | United States |
| Velicept Investigative Site - New Port Richey | New Port Richey | Florida | 34653 | United States |
| Velicept Investigative Site - Palm Harbor | Palm Harbor | Florida | 34684 | United States |
| Velicept Investigative Site - Pompano Beach | Pompano Beach | Florida | 33060 | United States |
| Velicept Investigative Site - Tampa | Tampa | Florida | 33615 | United States |
| Velicept Investigative Site - West Palm Beach | West Palm Beach | Florida | 33409 | United States |
| Velicept Investigative Site - Atlanta | Atlanta | Georgia | 30328 | United States |
| Velicept Investigative Site - Snellville | Snellville | Georgia | 30078 | United States |
| Velicept Investigative Site - Crowley | Crowley | Louisiana | 70526 | United States |
| Velicept Investigative Site - Metairie | Metairie | Louisiana | 70006 | United States |
| Velicept Investigative Site - Brighton | Brighton | Massachusetts | 02135 | United States |
| Velicept Investigative Site - North Dartmouth | North Dartmouth | Massachusetts | 02747 | United States |
| Velicept Investigative Site - Saginaw | Saginaw | Michigan | 48605 | United States |
| Velicept Investigative Site - Biloxi | Biloxi | Mississippi | 39531 | United States |
| Velicept Investigative Site - Olive Branch | Olive Branch | Mississippi | 38654 | United States |
| Velicept Investigative Site - La Vista | La Vista | Nebraska | 68128 | United States |
| Velicept Investigative Site - Las Vegas | Las Vegas | Nevada | 89109 | United States |
| Velicept Investigative Site - Las Vegas | Las Vegas | Nevada | 89117 | United States |
| Velicept Investigative Site - Las Vegas | Las Vegas | Nevada | 89128 | United States |
| Velicept Investigative Site - Edison | Edison | New Jersey | 08837 | United States |
| Velicept Investigative Site - Raleigh | Raleigh | North Carolina | 27612 | United States |
| Velicept Investigative Site - Fargo | Fargo | North Dakota | 58103 | United States |
| Velicept Investigative Site - Dayton | Dayton | Ohio | 45439 | United States |
| Velicept Investigative Site - Mustang | Mustang | Oklahoma | 73064 | United States |
| Velicept Investigative Site - Oklahoma City | Oklahoma City | Oklahoma | 73120 | United States |
| Velicept Investigative Site - Gresham | Gresham | Oregon | 97030 | United States |
| Velicept Investigative Site - Lansdale | Lansdale | Pennsylvania | 19446 | United States |
| Velicept Investigative Site - East Providence | East Providence | Rhode Island | 02914 | United States |
| Velicept Investigative Site - Lincoln | Lincoln | Rhode Island | 02865 | United States |
| Velicept Investigative Site - Charleston | Charleston | South Carolina | 29406 | United States |
| Velicept Investigative Site - Charleston | Charleston | South Carolina | 29407 | United States |
| Velicept Investigative Site - Fort Mill | Fort Mill | South Carolina | 29707 | United States |
| Velicept Investigative Site - Spartanburg | Spartanburg | South Carolina | 29301 | United States |
| Velicept Investigative Site - Chattanooga | Chattanooga | Tennessee | 37421 | United States |
| Velicept Investigative Site - Jackson | Jackson | Tennessee | 38301 | United States |
| Velicept Investigative Site - Knoxville | Knoxville | Tennessee | 37938 | United States |
| Velicept Investigative Site - Austin | Austin | Texas | 78704 | United States |
| Velicept Investigative Site - Austin | Austin | Texas | 78705 | United States |
| Velicept Investigative Site - Bryan | Bryan | Texas | 77802 | United States |
| Velicept Investigative Site - Carrollton | Carrollton | Texas | 75010 | United States |
| Velicept Investigative Site - Dallas | Dallas | Texas | 75224 | United States |
| Velicept Investigative Site - Fort Worth | Fort Worth | Texas | 76135 | United States |
| Velicept Investigative Site - Georgetown | Georgetown | Texas | 78626 | United States |
| Velicept Investigative Site - Houston | Houston | Texas | 77030 | United States |
| Velicept Investigative Site - Houston | Houston | Texas | 77082 | United States |
| Velicept Investigative Site - Plano(1) | Plano | Texas | 75024 | United States |
| Velicept Investigative Site - Plano(2) | Plano | Texas | 75024 | United States |
| Velicept Investigative Site - San Angelo | San Angelo | Texas | 76904 | United States |
| Velicept Investigative Site - San Antonio | San Antonio | Texas | 78209 | United States |
| Velicept Investigative Site - San Antonio | San Antonio | Texas | 78229 | United States |
| Velicept Investigative Site - Sugar Land | Sugar Land | Texas | 77478 | United States |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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