Status:
COMPLETED
Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women
Lead Sponsor:
Velicept Therapeutics, Inc.
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2019
Estimated Enrollment :
438 Patients enrolled
Trial Details
Trial ID
NCT03475706
Start Date
February 19 2018
End Date
January 30 2019
Last Update
March 2 2020
Active Locations (86)
Enter a location and click search to find clinical trials sorted by distance.
1
Velicept Investigative Site - Birmingham
Birmingham, Alabama, United States, 35205
2
Velicept Investigative Site - Gulf Shores
Gulf Shores, Alabama, United States, 36542
3
Velicept Investigative Site - Mobile
Mobile, Alabama, United States, 36608
4
Velicept Investigative Site - Tempe
Tempe, Arizona, United States, 85283