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



Status:Completed
Conditions:Overactive Bladder
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:2/6/2019
Start Date:February 19, 2018
End Date:January 30, 2019

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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

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.


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.
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