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) (VEL-2001)

A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Oral Solabegron Modified 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 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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: Solabegron modified release tablets, low dose; Drug: Solabegron modified release tablets, high dose; Drug: Matching Placebo

• Study Type: Interventional
• Enrollment (Actual): 1413
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Velicept Investigative Site - Birmingham
    • Birmingham, Alabama, United States, 35215
      • Velicept Investigative Site - Birmingham
    • Guntersville, Alabama, United States, 35976
      • Velicept Investigative Site - Guntersville
    • Saraland, Alabama, United States, 36571
      • Velicept Investigative Site - Saraland
  • Arizona
    • Tucson, Arizona, United States, 85741
      • Velicept Investigative Site - Tucson
    • Tucson, Arizona, United States, 85745
      • Velicept Investigative Site - Tucson
  • California
    • Lincoln, California, United States, 95648
      • Velicept Investigative Site - Lincoln
    • North Hollywood, California, United States, 91606
      • Velicept Investigative Site - North Hollywood
    • Sacramento, California, United States, 95864
      • Velicept Investigative Site - Sacramento
    • San Diego, California, United States, 92108
      • Velicept Investigative Site - San Diego
    • San Diego, California, United States, 92111
      • Velicept Investigative Site - San Diego
    • Spring Valley, California, United States, 91978
      • Velicept Investigative Site - Spring Valley
    • Upland, California, United States, 91786
      • Velicept Investigative Site - Upland
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Velicept Investigative Site - Aurora
    • Englewood, Colorado, United States, 80113
      • Velicept Investigative Site - Englewood
  • Connecticut
    • New London, Connecticut, United States, 06320
      • Velicept Investigative Site - New London
  • Florida
    • Aventura, Florida, United States, 33180
      • Velicept Investigative Site - Aventura
    • Doral, Florida, United States, 33166
      • Velicept Investigative Site - Doral
    • Doral, Florida, United States, 33166
      • Velicept Investigative Site - Doral(2)
    • Edgewater, Florida, United States, 32132
      • Velicept Investigative Site - Edgewater
    • Hialeah, Florida, United States, 33012
      • Velicept Investigative Site - Hialeah
    • Hollywood, Florida, United States, 33024
      • Velicept Investigative Site - Hollywood
    • Lauderdale Lakes, Florida, United States, 33319
      • Velicept Investigative Site - Lauderdale Lakes
    • Miami, Florida, United States, 33015
      • Velicept Investigative Site - Miami
    • Miami, Florida, United States, 33144
      • Velicept Investigative Site - Miami
    • Miami, Florida, United States, 33155
      • Velicept Investigative Site - Miami
    • Miami Springs, Florida, United States, 33166
      • Velicept Investigative Site - Miami Springs
    • New Port Richey, Florida, United States, 34653
      • Velicept Investigative Site - New Port Richey
    • Palm Harbor, Florida, United States, 34684
      • Velicept Investigative Site - Palm Harbor
    • Pompano Beach, Florida, United States, 33060
      • Velicept Investigative Site - Pompano Beach
    • Tampa, Florida, United States, 33615
      • Velicept Investigative Site - Tampa
    • West Palm Beach, Florida, United States, 33409
      • Velicept Investigative Site - West Palm Beach
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Velicept Investigative Site - Atlanta
    • Snellville, Georgia, United States, 30078
      • Velicept Investigative Site - Snellville
  • Louisiana
    • Crowley, Louisiana, United States, 70526
      • Velicept Investigative Site - Crowley
    • Metairie, Louisiana, United States, 70006
      • Velicept Investigative Site - Metairie
  • Massachusetts
    • Brighton, Massachusetts, United States, 02135
      • Velicept Investigative Site - Brighton
    • North Dartmouth, Massachusetts, United States, 02747
      • Velicept Investigative Site - North Dartmouth
  • Michigan
    • Saginaw, Michigan, United States, 48605
      • Velicept Investigative Site - Saginaw
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • Velicept Investigative Site - Biloxi
    • Olive Branch, Mississippi, United States, 38654
      • Velicept Investigative Site - Olive Branch
  • Nebraska
    • La Vista, Nebraska, United States, 68128
      • Velicept Investigative Site - La Vista
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Velicept Investigative Site - Las Vegas
    • Las Vegas, Nevada, United States, 89117
      • Velicept Investigative Site - Las Vegas
    • Las Vegas, Nevada, United States, 89128
      • Velicept Investigative Site - Las Vegas
  • New Jersey
    • Edison, New Jersey, United States, 08837
      • Velicept Investigative Site - Edison
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Velicept Investigative Site - Raleigh
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • Velicept Investigative Site - Fargo
  • Ohio
    • Dayton, Ohio, United States, 45439
      • Velicept Investigative Site - Dayton
  • Oklahoma
    • Mustang, Oklahoma, United States, 73064
      • Velicept Investigative Site - Mustang
    • Oklahoma City, Oklahoma, United States, 73120
      • Velicept Investigative Site - Oklahoma City
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Velicept Investigative Site - Gresham
  • Pennsylvania
    • Lansdale, Pennsylvania, United States, 19446
      • Velicept Investigative Site - Lansdale
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Velicept Investigative Site - East Providence
    • Lincoln, Rhode Island, United States, 02865
      • Velicept Investigative Site - Lincoln
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Velicept Investigative Site - Charleston
    • Charleston, South Carolina, United States, 29407
      • Velicept Investigative Site - Charleston
    • Fort Mill, South Carolina, United States, 29707
      • Velicept Investigative Site - Fort Mill
    • Spartanburg, South Carolina, United States, 29301
      • Velicept Investigative Site - Spartanburg
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Velicept Investigative Site - Chattanooga
    • Jackson, Tennessee, United States, 38301
      • Velicept Investigative Site - Jackson
    • Knoxville, Tennessee, United States, 37938
      • Velicept Investigative Site - Knoxville
  • Texas
    • Austin, Texas, United States, 78704
      • Velicept Investigative Site - Austin
    • Austin, Texas, United States, 78705
      • Velicept Investigative Site - Austin
    • Bryan, Texas, United States, 77802
      • Velicept Investigative Site - Bryan
    • Carrollton, Texas, United States, 75010
      • Velicept Investigative Site - Carrollton
    • Dallas, Texas, United States, 75224
      • Velicept Investigative Site - Dallas
    • Fort Worth, Texas, United States, 76135
      • Velicept Investigative Site - Fort Worth
    • Georgetown, Texas, United States, 78626
      • Velicept Investigative Site - Georgetown
    • Houston, Texas, United States, 77030
      • Velicept Investigative Site - Houston
    • Houston, Texas, United States, 77082
      • Velicept Investigative Site - Houston
    • Plano, Texas, United States, 75024
      • Velicept Investigative Site - Plano(1)
    • Plano, Texas, United States, 75024
      • Velicept Investigative Site - Plano(2)
    • San Angelo, Texas, United States, 76904
      • Velicept Investigative Site - San Angelo
    • San Antonio, Texas, United States, 78209
      • Velicept Investigative Site - San Antonio
    • San Antonio, Texas, United States, 78229
      • Velicept Investigative Site - San Antonio
    • Sugar Land, Texas, United States, 77478
      • Velicept Investigative Site - Sugar Land

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Comparator	Drug: Matching Placebo; Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.
Experimental: Solabegron modified release tablets low dose	Drug: Solabegron modified release tablets, low dose; Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.
Experimental: Solabegron modified release tablets high dose	Drug: Solabegron modified release tablets, high dose; Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in mean number of micturitions per 24 hours at Week 12	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.	Micturtions will be assessed prior to randomization and at Week 12 (Visit 6).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Incontinence (1)	Change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urinary Incontinence (2)	Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urinary Incontinence (3)	Proportion of subjects with no episodes of urgency urinary incontinence per 24 hours	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urinary Incontinence (4)	Proportion of subjects with no episodes of urinary incontinence (urgency and non-urgency) per 24 hours	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urinary Incontinence (5)	Change from Baseline in total urinary incontinence episodes (urgency and non-urgency) per 24 hours	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Micturitions (1)	Change from Baseline in mean number of micturitions per 24 hours	Prior to Randomization (Baseline) and at Weeks 4 and 8
Micturitions (2)	Percentage change from Baseline in mean number of micturitions per 24 hours	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Micturitions (3)	Percentage of subjects with < 8 micturitions per 24 hours	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Micturitions (4)	Change from Baseline in mean number of nocturnal voids per 24 hours	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (1)	Change from Baseline in average void volume over 24 hours	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (2)	Percentage change from Baseline in average void volume over 24 hours	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (3)	Change from Baseline in maximum individual void volume over 24 hours	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (4)	Percentage change from Baseline in maximum individual void volume over 24 hours	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urgency (1)	Proportion of subjects with urges with a mean grade of 3 of 4 per 24 hours	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urgency (2)	Change from Baseline in mean urgency assessments per 24 hours associated with micturitions or incontinence	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Patient Reported Outcomes (1)	Patient Perception of Bladder Control. This patient-reported questionnaire assesses the patient's perception of current urinary problems, where higher score (on a scale of 1 to 6) indicates more severe problems.	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Patient Reported Outcomes (2)	Change from Baseline in Symptom Bother Score (Overactive Bladder Questionnaire [OAB-q] short form). The OAB-q short form is completed as a 4-week recall where a higher score (on a scale of 1 to 6) indicates greater symptoms.	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Patient Reported Outcomes (3)	Change from Baseline in health-related quality of life (Overactive Bladder Questionnaire [OAB-q] short form). The OAB-q short form is completed as a 4-week recall where a higher score (on a scale of 1 to 6) indicates worse health-related quality of life.	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12

Collaborators and Investigators

• Sponsor: Velicept Therapeutics, Inc.

Publications and helpful links

General Publications

• Ohlstein EH, von Keitz A, Michel MC. A multicenter, double-blind, randomized, placebo-controlled trial of the beta3-adrenoceptor agonist solabegron for overactive bladder. Eur Urol. 2012 Nov;62(5):834-40. doi: 10.1016/j.eururo.2012.05.053. Epub 2012 Jun 5.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2018
• Primary Completion (Actual): April 29, 2019
• Study Completion (Actual): May 2, 2019

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: overactive bladder; urgency; urinary conditions; urgency urinary incontinence; micturitions
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agonists; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Solabegron
• Other Study ID Numbers: VEL-2001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No