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

Completed · Phase 2 · Has a placebo group

Conditions studied: Overactive Bladder

In brief

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.

Key facts

Study ID

NCT03475706

Run by

Velicept Therapeutics, Inc.

People needed

438

Starts

2018-02-19

Expected to finish

2019-01-30

Last updated by the study team

2020-03-02

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• 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
• Velicept Investigative Site - Los Alamitos — Los Alamitos, California, United States
• Velicept Investigative Site - Los Angeles — Los Angeles, California, United States
• Velicept Investigative Site - Norco — Norco, California, United States
• Velicept Investigative Site - Sacramento — Sacramento, California, United States
• Velicept Investigative Site - San Diego — San Diego, California, United States
• Velicept Investigative Site - San Diego — San Diego, California, United States
• Velicept Investigative Site - San Marcos — San Marcos, California, United States
• Velicept Investigative Site - Thousand Oaks — Thousand Oaks, California, United States
• Velicept Investigative Site - Denver — Denver, Colorado, United States
• Velicept Investigative Site - Waterbury — Waterbury, Connecticut, United States
• Velicept Investigative Site - Clearwater — Clearwater, Florida, United States
• Velicept Investigative Site - Deland — DeLand, Florida, United States
• Velicept Investigative Site - Doral — Doral, Florida, United States
• Velicept Investigative Site - Jupiter — Jupiter, Florida, United States
• Velicept Investigative Site - Lake City — Lake City, Florida, United States
• Velicept Investigative Site - Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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