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

Status and phase

Completed

Phase 2

Conditions

Overactive Bladder

Treatments

Drug: Solabegron modified release tablets, high dose

Drug: Matching Placebo

Drug: Solabegron modified release tablets, low dose

Study type

Interventional

Funder types

Industry

Identifiers

NCT03594058

VEL-2001

Details and patient eligibility

About

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.

Enrollment

1,413 patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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