Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women

Velicept Therapeutics, Inc.438 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

438

Conditions

Overactive Bladder

Interventions

Solabegron immediate release tablets, low doseDRUG

twice daily for 12 weeks.

Solabegron immediate release tablets, high doseDRUG

twice daily for 12 weeks.

Matching PlaceboDRUG

twice daily for 12 weeks.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (86)

Outcomes

Primary Outcomes

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.

Time frame: Micturitions will be assessed prior to randomization and at Week 12 (Visit 6).

Secondary Outcomes

Urinary Incontinence (1)

Change from Baseline in mean number of urgency urinary incontinence episodes per 24h.

Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12

Urinary Incontinence (2)

Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24h.

Time frame: Prior to Randomization (Baseline) and at Weeks 4 and 8

Urinary Incontinence (3)

Proportion of subjects with no episodes of urgency urinary incontinence per 24h.

Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12

Urinary Incontinence (4)

Proportion of subjects with no episodes of urinary incontinence (urgency or non-urgency) per 24h.

Time frame: 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 24h.

Time frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12

Micturitions (1)

Change from Baseline in mean number of micturitions per 24h.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Velicept Investigative Site - Birmingham

Birmingham, Alabama, United States

Velicept Investigative Site - Gulf Shores

Gulf Shores, Alabama, United States

Velicept Investigative Site - Mobile

Mobile, Alabama, United States

Velicept Investigative Site - Tempe

Tempe, Arizona, United States

Velicept Investigative Site - Tucson

Tucson, Arizona, United States

Velicept Investigative Site - Little Rock

Little Rock, Arkansas, United States

Velicept Investigative Site - Anaheim

Anaheim, California, United States

Velicept Investigative Site - Arcadia

Arcadia, California, United States

Velicept Investigative Site - Canoga Park

Canoga Park, California, United States

Velicept Investigative Site - Huntington Beach

Huntington Beach, California, United States

...and 76 more locations