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)

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 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.

Key facts

Study ID

NCT03594058

Run by

Velicept Therapeutics, Inc.

People needed

1413

Starts

2018-07-09

Expected to finish

2019-05-02

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, 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).

You may not qualify if…

• 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

Where it is running

• Velicept Investigative Site - Birmingham — Birmingham, Alabama, United States
• Velicept Investigative Site - Guntersville — Guntersville, Alabama, United States
• Velicept Investigative Site - Saraland — Saraland, Alabama, United States
• Velicept Investigative Site - Tucson — Tucson, Arizona, United States
• Velicept Investigative Site - Tucson — Tucson, Arizona, United States
• Velicept Investigative Site - Lincoln — Lincoln, California, United States
• Velicept Investigative Site - North Hollywood — North Hollywood, 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 - Spring Valley — Spring Valley, California, United States
• Velicept Investigative Site - Upland — Upland, California, United States
• Velicept Investigative Site - Aurora — Aurora, Colorado, United States
• Velicept Investigative Site - Englewood — Englewood, Colorado, United States
• Velicept Investigative Site - New London — New London, Connecticut, United States
• Velicept Investigative Site - Aventura — Aventura, Florida, United States
• Velicept Investigative Site - Doral(2) — Doral, Florida, United States
• Velicept Investigative Site - Doral — Doral, Florida, United States
• Velicept Investigative Site - Edgewater — Edgewater, Florida, United States
• Velicept Investigative Site - Hialeah — Hialeah, Florida, United States
• Velicept Investigative Site - Hollywood — Hollywood, Florida, United States
• Velicept Investigative Site - Lauderdale Lakes — Lauderdale Lakes, Florida, United States
• Velicept Investigative Site - Miami — Miami, Florida, United States
• Velicept Investigative Site - Miami — Miami, Florida, United States
• Velicept Investigative Site - Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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