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)

Velicept Therapeutics, Inc.1,413 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 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,413

Conditions

Overactive Bladder

Interventions

Solabegron modified release tablets, low dose

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, 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

Locations (77)

Velicept Investigative Site - Birmingham

Birmingham, Alabama, United States

Velicept Investigative Site - Birmingham

Birmingham, Alabama, United States

Velicept Investigative Site - Guntersville

Guntersville, Alabama, United States

Velicept Investigative Site - Saraland

Saraland, Alabama, United States

Velicept Investigative Site - Tucson

Tucson, Arizona, United States

Outcomes

Primary Outcomes

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.

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