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)

Overactive Bladder Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03594058
• Other study ID #: VEL-2001
• Status: Completed
• Phase: Phase 2
• Start date: July 9, 2018
• Est. completion date: May 2, 2019

Study information

• Verified date: August 2019
• Source: Velicept Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Solabegron modified release tablets, low dose
Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.
• Solabegron modified release tablets, high dose
Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.
• Matching Placebo
Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Velicept Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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