A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Oral Solabegron Immediate Release Tablets in the Treatment of Overactive Bladder (OAB) in Adult Female Subjects

Velicept Therapeutics, Inc.80 sites in 1 country438 target enrollmentFebruary 19, 2018

InterventionsSolabegron immediate release tablets, low dose Solabegron immediate release tablets, high dose Matching Placebo

DrugsSolabegron immediate release tablets, low dose Solabegron immediate release tablets, high dose Matching Placebo

Overview

Phase: Phase 2
Intervention: Solabegron immediate release tablets, low dose
Conditions: Overactive Bladder
Sponsor: Velicept Therapeutics, Inc.
Enrollment: 438
Locations: 80
Primary Endpoint: Change from Baseline in mean number of micturitions per 24h at Week 12
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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 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.

Registry

clinicaltrials.gov

Start Date

February 19, 2018

End Date

January 30, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Velicept Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Solabegron immediate release tablets low dose

Intervention: Solabegron immediate release tablets, low dose

Solabegron immediate release tablets high dose

Intervention: Solabegron immediate release tablets, high dose

Placebo Comparator

Intervention: Matching Placebo

Outcomes

Primary Outcomes

Change from Baseline in mean number of micturitions per 24h at Week 12

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

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.

Secondary Outcomes

Urinary Incontinence (5)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Micturitions (1)(Prior to Randomization (Baseline) and at Weeks 4 and 8)
Micturitions (4)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Urine Void Volume (1)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Urine Void Volume (2)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Urine Void Volume (3)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Urine Void Volume (4)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Urgency (1)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Urgency (2)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Patient Reported Outcomes (1)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Patient Reported Outcomes (2)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Urinary Incontinence (1)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Micturitions (3)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Urinary Incontinence (4)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Urinary Incontinence (2)(Prior to Randomization (Baseline) and at Weeks 4 and 8)
Micturitions (2)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Urinary Incontinence (3)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
Patient Reported Outcomes (3)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)