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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 438
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Velicept Investigative Site - Birmingham
    • Gulf Shores, Alabama, United States, 36542
      • Velicept Investigative Site - Gulf Shores
    • Mobile, Alabama, United States, 36608
      • Velicept Investigative Site - Mobile
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Velicept Investigative Site - Tempe
    • Tucson, Arizona, United States, 87504
      • Velicept Investigative Site - Tucson
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Velicept Investigative Site - Little Rock
  • California
    • Anaheim, California, United States, 92801
      • Velicept Investigative Site - Anaheim
    • Arcadia, California, United States, 91007
      • Velicept Investigative Site - Arcadia
    • Canoga Park, California, United States, 91303
      • Velicept Investigative Site - Canoga Park
    • Huntington Beach, California, United States, 92647
      • Velicept Investigative Site - Huntington Beach
    • Los Alamitos, California, United States, 90720
      • Velicept Investigative Site - Los Alamitos
    • Los Angeles, California, United States, 90017
      • Velicept Investigative Site - Los Angeles
    • Norco, California, United States, 92860
      • Velicept Investigative Site - Norco
    • Sacramento, California, United States, 95821
      • Velicept Investigative Site - Sacramento
    • San Diego, California, United States, 92103
      • Velicept Investigative Site - San Diego
    • San Diego, California, United States, 92123
      • Velicept Investigative Site - San Diego
    • San Marcos, California, United States, 92078
      • Velicept Investigative Site - San Marcos
    • Thousand Oaks, California, United States, 91360
      • Velicept Investigative Site - Thousand Oaks
  • Colorado
    • Denver, Colorado, United States, 80209
      • Velicept Investigative Site - Denver
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Velicept Investigative Site - Waterbury
  • Florida
    • Clearwater, Florida, United States, 33761
      • Velicept Investigative Site - Clearwater
    • DeLand, Florida, United States, 32720
      • Velicept Investigative Site - Deland
    • Doral, Florida, United States, 33166
      • Velicept Investigative Site - Doral
    • Jupiter, Florida, United States, 33458
      • Velicept Investigative Site - Jupiter
    • Lake City, Florida, United States, 32055
      • Velicept Investigative Site - Lake City
    • Miami, Florida, United States, 33135
      • Velicept Investigative Site - Miami
    • Miami, Florida, United States, 33176
      • Velicept Investigative Site - Miami
    • Miami, Florida, United States, 33186
      • Velicept Investigative Site - Miami
    • Ponte Vedra, Florida, United States, 32081
      • Velicept Investigative Site - Ponte Vedra
    • Port Saint Lucie, Florida, United States, 34952
      • Velicept Investigative Site - Port St Lucie
    • West Palm Beach, Florida, United States, 33409
      • Velicept Investigative Site - West Palm Beach
    • Winter Haven, Florida, United States, 33880
      • Velicept Investigative Site - Winter Haven
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Velicept Investigative Site - Marietta
  • Idaho
    • Blackfoot, Idaho, United States, 83221
      • Velicept Investigative Site - Blackfoot
    • Meridian, Idaho, United States, 83642
      • Velicept Investigative Site - Meridian
  • Illinois
    • Wauconda, Illinois, United States, 60084
      • Velicept Investigative Site - Wauconda
  • Indiana
    • Elwood, Indiana, United States, 46036
      • Velicept Investigative Site - Elwood
    • Evansville, Indiana, United States, 47714
      • Velicept Investigative Site - Evansville
  • Kansas
    • Newton, Kansas, United States, 67114
      • Velicept Investigative Site - Newton
  • Kentucky
    • Louisville, Kentucky, United States, 40291
      • Velicept Investigative Site - Louisville
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • Velicept Investigative Site - Metairie
    • New Orleans, Louisiana, United States, 70115
      • Velicept Investigative Site - New Orleans
    • Shreveport, Louisiana, United States, 71106
      • Velicept Investigative Site - Shreveport
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Velicept Investigative Site - Boston
    • New Bedford, Massachusetts, United States, 02740
      • Velicept Investigative Site - New Bedford
    • North Attleboro, Massachusetts, United States, 02760
      • Velicept Investigative Site - North Attleborro
    • Watertown, Massachusetts, United States, 02472
      • Velicept Investigative Site - Watertown
  • Michigan
    • Kalamazoo, Michigan, United States, 49009
      • Velicept Investigative Site - Kalamazoo
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Velicept Investigative Site - St. Louis
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Velicept Investigative Site - Omaha
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Velicept Investigative Site - Las Vegas
  • New Jersey
    • Brick, New Jersey, United States, 08724
      • Velicept Investigative Site - Brick
    • Voorhees, New Jersey, United States, 08043
      • Velicept Investigative Site - Vorhees
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Velicept Investigative Site - Albuquerque
  • New York
    • New York, New York, United States, 10016
      • Velicept Investigative Site - New York
    • Williamsville, New York, United States, 14221
      • Velicept Investigative Site - Williamsville
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Velicept Investigative Site - Charlotte
    • Wilmington, North Carolina, United States, 28401
      • Velicept Investigative Site - Wilmington
    • Winston-Salem, North Carolina, United States, 27103
      • Velicept Investigative Site - Winston-Salem
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Velicept Investigative Site - Cincinnati
    • Cleveland, Ohio, United States, 44122
      • Velicept Investigative Site - Cleveland
    • Columbus, Ohio, United States, 43123
      • Velicept Investigative Site - Columbus
    • Marion, Ohio, United States, 43302
      • Velicept Investigative Site - Marion
    • Middleburg Heights, Ohio, United States, 44130
      • Velicept Investigative Site - Middleburg Heights
  • Rhode Island
    • Warwick, Rhode Island, United States, 02818
      • Velicept Investigative Site - Warwick
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Velicept Investigative Site - Mt. Pleasant
    • Myrtle Beach, South Carolina, United States, 29572
      • Velicept Investigative Site - Myrtle Beach
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • Velicept Investigative Site - Jackson
    • Knoxville, Tennessee, United States, 37920
      • Velicept Investigative Site - Knoxville
    • Nashville, Tennessee, United States, 37203
      • Velicept Investigative Site - Nashville
  • Texas
    • Austin, Texas, United States, 78735
      • Velicept Investigative Site - Austin
    • Beaumont, Texas, United States, 77702
      • Velicept Investigative Site - Beaumont
    • Lampasas, Texas, United States, 76550
      • Velicept Investigative Site - Lampasas
    • Longview, Texas, United States, 80209
      • Velicept Investigative Site - Longview
    • San Antonio, Texas, United States, 78209
      • Velicept Investigative Site - San Antonio
    • San Antonio, Texas, United States, 78229
      • Velicept Investigative Site - San Antonio
    • San Antonio, Texas, United States, 78249
      • Velicept Investigative Site - San Antonio
  • Utah
    • Clinton, Utah, United States, 84015
      • Velicept Investigative Site - Clinton
    • Saint George, Utah, United States, 84790
      • Velicept Investigative Site - St. George
    • Salt Lake City, Utah, United States, 84107
      • Velicept Investigative Site - Salt Lake City
    • Salt Lake City, Utah, United States, 84124
      • Velicept Investigative Site - Salt Lake City
    • West Jordan, Utah, United States, 84088
      • Velicept Investigative Site - West Jordan
  • Virginia
    • Newport News, Virginia, United States, 23606
      • Velicept Investigative Site - Newport News
    • Norfolk, Virginia, United States, 23507
      • Velicept Investigative Site - Norfolk
  • Washington
    • Tacoma, Washington, United States, 98405
      • Velicept Investigative Site - Tacoma
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Velicept Investigative Site - Kenosha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 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, 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.

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; twice daily for 12 weeks.
Experimental: Solabegron immediate release tablets low dose	Drug: Solabegron immediate release tablets, low dose; twice daily for 12 weeks.
Experimental: Solabegron immediate release tablets high dose	Drug: Solabegron immediate release tablets, high dose; twice 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 24h 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.	Micturitions 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 24h.	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 24h.	Prior to Randomization (Baseline) and at Weeks 4 and 8
Urinary Incontinence (3)	Proportion of subjects with no episodes of urgency urinary incontinence per 24h.	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urinary Incontinence (4)	Proportion of subjects with no episodes of urinary incontinence (urgency or non-urgency) per 24h.	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 24h.	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Micturitions (1)	Change from Baseline in mean number of micturitions per 24h.	Prior to Randomization (Baseline) and at Weeks 4 and 8
Micturitions (2)	Percentage change from Baseline in mean number of micturitions per 24h.	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Micturitions (3)	Percentage of subjects with <8 micturitions per 24h.	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Micturitions (4)	Change from Baseline in mean number of nocturnal voids per 24h.	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (1)	Change from Baseline in average void volume over 24h.	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (2)	Percentage change from Baseline in average void volume over 24h.	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urine Void Volume (3)	Change from Baseline in maximum individual void volume over 24h.	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 24h.	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urgency (1)	Proportion of subjects with urges with a mean grade of 3 or 4 per 24h.	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Urgency (2)	Change from Baseline in urgency assessments per 24h associated with micturitions and incontinence.	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Patient Reported Outcomes (1)	Patient Perception of Bladder Condition	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Patient Reported Outcomes (2)	Change from Baseline in Symptom Bother Score (OAB-q short form).	Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Patient Reported Outcomes (3)	Change from Baseline in health-related quality of life (OAB-q short form).	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): February 19, 2018
• Primary Completion (Actual): January 24, 2019
• Study Completion (Actual): January 30, 2019

Study Registration Dates

• First Submitted: March 12, 2018
• First Submitted That Met QC Criteria: March 16, 2018
• First Posted (Actual): March 23, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2020
• Last Update Submitted That Met QC Criteria: February 27, 2020
• Last Verified: January 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-2002

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