Overactive Bladder Clinical Trial
— VEL-2001Official 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
| NCT number | NCT03594058 |
| Other study ID # | VEL-2001 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | July 9, 2018 |
| Est. completion date | May 2, 2019 |
| Verified date | August 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 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.
| Status | Completed |
| Enrollment | 1413 |
| Est. completion date | May 2, 2019 |
| Est. primary completion date | April 29, 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, 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Velicept Investigative Site - Atlanta | Atlanta | Georgia |
| United States | Velicept Investigative Site - Aurora | Aurora | Colorado |
| United States | Velicept Investigative Site - Austin | Austin | Texas |
| United States | Velicept Investigative Site - Austin | Austin | Texas |
| United States | Velicept Investigative Site - Aventura | Aventura | Florida |
| United States | Velicept Investigative Site - Biloxi | Biloxi | Mississippi |
| United States | Velicept Investigative Site - Birmingham | Birmingham | Alabama |
| United States | Velicept Investigative Site - Birmingham | Birmingham | Alabama |
| United States | Velicept Investigative Site - Brighton | Brighton | Massachusetts |
| United States | Velicept Investigative Site - Bryan | Bryan | Texas |
| United States | Velicept Investigative Site - Carrollton | Carrollton | Texas |
| United States | Velicept Investigative Site - Charleston | Charleston | South Carolina |
| United States | Velicept Investigative Site - Charleston | Charleston | South Carolina |
| United States | Velicept Investigative Site - Chattanooga | Chattanooga | Tennessee |
| United States | Velicept Investigative Site - Crowley | Crowley | Louisiana |
| United States | Velicept Investigative Site - Dallas | Dallas | Texas |
| United States | Velicept Investigative Site - Dayton | Dayton | Ohio |
| United States | Velicept Investigative Site - Doral | Doral | Florida |
| United States | Velicept Investigative Site - Doral(2) | Doral | Florida |
| United States | Velicept Investigative Site - East Providence | East Providence | Rhode Island |
| United States | Velicept Investigative Site - Edgewater | Edgewater | Florida |
| United States | Velicept Investigative Site - Edison | Edison | New Jersey |
| United States | Velicept Investigative Site - Englewood | Englewood | Colorado |
| United States | Velicept Investigative Site - Fargo | Fargo | North Dakota |
| United States | Velicept Investigative Site - Fort Mill | Fort Mill | South Carolina |
| United States | Velicept Investigative Site - Fort Worth | Fort Worth | Texas |
| United States | Velicept Investigative Site - Georgetown | Georgetown | Texas |
| United States | Velicept Investigative Site - Gresham | Gresham | Oregon |
| United States | Velicept Investigative Site - Guntersville | Guntersville | Alabama |
| United States | Velicept Investigative Site - Hialeah | Hialeah | Florida |
| United States | Velicept Investigative Site - Hollywood | Hollywood | Florida |
| United States | Velicept Investigative Site - Houston | Houston | Texas |
| United States | Velicept Investigative Site - Houston | Houston | Texas |
| United States | Velicept Investigative Site - Jackson | Jackson | Tennessee |
| United States | Velicept Investigative Site - Knoxville | Knoxville | Tennessee |
| United States | Velicept Investigative Site - La Vista | La Vista | Nebraska |
| United States | Velicept Investigative Site - Lansdale | Lansdale | Pennsylvania |
| United States | Velicept Investigative Site - Las Vegas | Las Vegas | Nevada |
| United States | Velicept Investigative Site - Las Vegas | Las Vegas | Nevada |
| United States | Velicept Investigative Site - Las Vegas | Las Vegas | Nevada |
| United States | Velicept Investigative Site - Lauderdale Lakes | Lauderdale Lakes | Florida |
| United States | Velicept Investigative Site - Lincoln | Lincoln | California |
| United States | Velicept Investigative Site - Lincoln | Lincoln | Rhode Island |
| 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 - Miami Springs | Miami Springs | Florida |
| United States | Velicept Investigative Site - Mustang | Mustang | Oklahoma |
| United States | Velicept Investigative Site - New London | New London | Connecticut |
| United States | Velicept Investigative Site - New Port Richey | New Port Richey | Florida |
| United States | Velicept Investigative Site - North Dartmouth | North Dartmouth | Massachusetts |
| United States | Velicept Investigative Site - North Hollywood | North Hollywood | California |
| United States | Velicept Investigative Site - Oklahoma City | Oklahoma City | Oklahoma |
| United States | Velicept Investigative Site - Olive Branch | Olive Branch | Mississippi |
| United States | Velicept Investigative Site - Palm Harbor | Palm Harbor | Florida |
| United States | Velicept Investigative Site - Plano(1) | Plano | Texas |
| United States | Velicept Investigative Site - Plano(2) | Plano | Texas |
| United States | Velicept Investigative Site - Pompano Beach | Pompano Beach | Florida |
| United States | Velicept Investigative Site - Raleigh | Raleigh | North Carolina |
| United States | Velicept Investigative Site - Sacramento | Sacramento | California |
| United States | Velicept Investigative Site - Saginaw | Saginaw | Michigan |
| United States | Velicept Investigative Site - San Angelo | San Angelo | 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 - Saraland | Saraland | Alabama |
| United States | Velicept Investigative Site - Snellville | Snellville | Georgia |
| United States | Velicept Investigative Site - Spartanburg | Spartanburg | South Carolina |
| United States | Velicept Investigative Site - Spring Valley | Spring Valley | California |
| United States | Velicept Investigative Site - Sugar Land | Sugar Land | Texas |
| United States | Velicept Investigative Site - Tampa | Tampa | Florida |
| United States | Velicept Investigative Site - Tucson | Tucson | Arizona |
| United States | Velicept Investigative Site - Tucson | Tucson | Arizona |
| United States | Velicept Investigative Site - Upland | Upland | California |
| United States | Velicept Investigative Site - West Palm Beach | West Palm Beach | 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 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). | |
| Secondary | 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 | |
| Secondary | Urinary Incontinence (2) | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Micturitions (1) | Change from Baseline in mean number of micturitions per 24 hours | Prior to Randomization (Baseline) and at Weeks 4 and 8 | |
| Secondary | 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 | |
| Secondary | Micturitions (3) | Percentage of subjects with < 8 micturitions per 24 hours | Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
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