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

NCT03475706 | Completed Phase 2 FDA Drug

• 1 other identifier: VEL-2002
• Study Type: interventional
• Target: 438
• Locations: 1 country
• Sites: 86

Brief Summary

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.

Conditions

Overactive Bladder

Keywords

overactive bladder; urinary conditions; urgency urinary incontinence; urgency; micturitions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (18)

• Urinary Incontinence (1)

  Prior to Randomization (Baseline) and at Weeks 4, 8, and 12

• Urinary Incontinence (2)

  Prior to Randomization (Baseline) and at Weeks 4 and 8

• Urinary Incontinence (3)

  Prior to Randomization (Baseline) and at Weeks 4, 8, and 12

• Urinary Incontinence (4)

  Prior to Randomization (Baseline) and at Weeks 4, 8, and 12

• Urinary Incontinence (5)

  Prior to Randomization (Baseline) and at Weeks 4, 8, and 12

Study Arms (3)

Solabegron immediate release tablets low dose

EXPERIMENTAL

Drug: Solabegron immediate release tablets, low dose

Solabegron immediate release tablets high dose

EXPERIMENTAL

Drug: Solabegron immediate release tablets, high dose

Placebo Comparator

PLACEBO COMPARATOR

Drug: Matching Placebo

Interventions

Solabegron immediate release tablets, low dose DRUG

twice daily for 12 weeks.

Solabegron immediate release tablets low dose

Solabegron immediate release tablets, high dose DRUG

twice daily for 12 weeks.

Solabegron immediate release tablets high dose

Matching Placebo DRUG

twice daily for 12 weeks.

Placebo Comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Velicept Therapeutics, Inc.: lead

Study Sites (86)

Velicept Investigative Site - Birmingham

Birmingham, Alabama, 35205, United States

Location

Velicept Investigative Site - Gulf Shores

Gulf Shores, Alabama, 36542, United States

Location

Velicept Investigative Site - Mobile

Mobile, Alabama, 36608, United States

Location

Velicept Investigative Site - Tempe

Tempe, Arizona, 85283, United States

Location

Velicept Investigative Site - Tucson

Tucson, Arizona, 87504, United States

Location

Velicept Investigative Site - Little Rock

Little Rock, Arkansas, 72212, United States

Location

Velicept Investigative Site - Anaheim

Anaheim, California, 92801, United States

Location

Velicept Investigative Site - Arcadia

Arcadia, California, 91007, United States

Location

Velicept Investigative Site - Canoga Park

Canoga Park, California, 91303, United States

Location

Velicept Investigative Site - Huntington Beach

Huntington Beach, California, 92647, United States

Location

Velicept Investigative Site - Los Alamitos

Los Alamitos, California, 90720, United States

Location

Velicept Investigative Site - Los Angeles

Los Angeles, California, 90017, United States

Location

Velicept Investigative Site - Norco

Norco, California, 92860, United States

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Velicept Investigative Site - Sacramento

Sacramento, California, 95821, United States

Location

Velicept Investigative Site - San Diego

San Diego, California, 92103, United States

Location

Velicept Investigative Site - San Diego

San Diego, California, 92123, United States

Location

Velicept Investigative Site - San Marcos

San Marcos, California, 92078, United States

Location

Velicept Investigative Site - Thousand Oaks

Thousand Oaks, California, 91360, United States

Location

Velicept Investigative Site - Denver

Denver, Colorado, 80209, United States

Location

Velicept Investigative Site - Waterbury

Waterbury, Connecticut, 06708, United States

Location

Velicept Investigative Site - Clearwater

Clearwater, Florida, 33761, United States

Location

Velicept Investigative Site - Deland

DeLand, Florida, 32720, United States

Location

Velicept Investigative Site - Doral

Doral, Florida, 33166, United States

Location

Velicept Investigative Site - Jupiter

Jupiter, Florida, 33458, United States

Location

Velicept Investigative Site - Lake City

Lake City, Florida, 32055, United States

Location

Velicept Investigative Site - Miami

Miami, Florida, 33135, United States

Location

Velicept Investigative Site - Miami

Miami, Florida, 33176, United States

Location

Velicept Investigative Site - Miami

Miami, Florida, 33186, United States

Location

Velicept Investigative Site - Ponte Vedra

Ponte Vedra, Florida, 32081, United States

Location

Velicept Investigative Site - Port St Lucie

Port Saint Lucie, Florida, 34952, United States

Location

Velicept Investigative Site - West Palm Beach

West Palm Beach, Florida, 33409, United States

Location

Velicept Investigative Site - Winter Haven

Winter Haven, Florida, 33880, United States

Location

Velicept Investigative Site - Marietta

Marietta, Georgia, 30060, United States

Location

Velicept Investigative Site - Blackfoot

Blackfoot, Idaho, 83221, United States

Location

Velicept Investigative Site - Meridian

Meridian, Idaho, 83642, United States

Location

Velicept Investigative Site - Wauconda

Wauconda, Illinois, 60084, United States

Location

Velicept Investigative Site - Elwood

Elwood, Indiana, 46036, United States

Location

Velicept Investigative Site - Evansville

Evansville, Indiana, 47714, United States

Location

Velicept Investigative Site - Newton

Newton, Kansas, 67114, United States

Location

Velicept Investigative Site - Louisville

Louisville, Kentucky, 40291, United States

Location

Velicept Investigative Site - Metairie

Metairie, Louisiana, 70001, United States

Location

Velicept Investigative Site - New Orleans

New Orleans, Louisiana, 70115, United States

Location

Velicept Investigative Site - Shreveport

Shreveport, Louisiana, 71106, United States

Location

Velicept Investigative Site - Boston

Boston, Massachusetts, 02131, United States

Location

Velicept Investigative Site - New Bedford

New Bedford, Massachusetts, 02740, United States

Location

Velicept Investigative Site - North Attleborro

North Attleboro, Massachusetts, 02760, United States

Location

Velicept Investigative Site - Watertown

Watertown, Massachusetts, 02472, United States

Location

Velicept Investigative Site - Kalamazoo

Kalamazoo, Michigan, 49009, United States

Location

Velicept Investigative Site - St. Louis

St Louis, Missouri, 63141, United States

Location

Velicept Investigative Site - Omaha

Omaha, Nebraska, 68114, United States

Location

Velicept Investigative Site - Las Vegas

Las Vegas, Nevada, 89119, United States

Location

Velicept Investigative Site - Brick

Brick, New Jersey, 08724, United States

Location

Velicept Investigative Site - Vorhees

Voorhees Township, New Jersey, 08043, United States

Location

Velicept Investigative Site - Albuquerque

Albuquerque, New Mexico, 87102, United States

Location

Velicept Investigative Site - New York

New York, New York, 10016, United States

Location

Velicept Investigative Site - Williamsville

Williamsville, New York, 14221, United States

Location

Velicept Investigative Site - Charlotte

Charlotte, North Carolina, 28203, United States

Location

Velicept Investigative Site - Wilmington

Wilmington, North Carolina, 28401, United States

Location

Velicept Investigative Site - Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Velicept Investigative Site - Cincinnati

Cincinnati, Ohio, 45236, United States

Location

Velicept Investigative Site - Cleveland

Cleveland, Ohio, 44122, United States

Location

Velicept Investigative Site - Columbus

Columbus, Ohio, 43123, United States

Location

Velicept Investigative Site - Marion

Marion, Ohio, 43302, United States

Location

Velicept Investigative Site - Middleburg Heights

Middleburg Heights, Ohio, 44130, United States

Location

Velicept Investigative Site - Warwick

Warwick, Rhode Island, 02818, United States

Location

Velicept Investigative Site - Mt. Pleasant

Mt. Pleasant, South Carolina, 29464, United States

Location

Velicept Investigative Site - Myrtle Beach

Myrtle Beach, South Carolina, 29572, United States

Location

Velicept Investigative Site - Jackson

Jackson, Tennessee, 38305, United States

Location

Velicept Investigative Site - Knoxville

Knoxville, Tennessee, 37920, United States

Location

Velicept Investigative Site - Nashville

Nashville, Tennessee, 37203, United States

Location

Velicept Investigative Site - Austin

Austin, Texas, 78735, United States

Location

Velicept Investigative Site - Beaumont

Beaumont, Texas, 77702, United States

Location

Velicept Investigative Site - Lampasas

Lampasas, Texas, 76550, United States

Location

Velicept Investigative Site - Longview

Longview, Texas, 80209, United States

Location

Velicept Investigative Site - San Antonio

San Antonio, Texas, 78209, United States

Location

Velicept Investigative Site - San Antonio

San Antonio, Texas, 78229, United States

Location

Velicept Investigative Site - San Antonio

San Antonio, Texas, 78249, United States

Location

Velicept Investigative Site - Clinton

Clinton, Utah, 84015, United States

Location

Velicept Investigative Site - Salt Lake City

Salt Lake City, Utah, 84107, United States

Location

Velicept Investigative Site - Salt Lake City

Salt Lake City, Utah, 84124, United States

Location

Velicept Investigative Site - St. George

St. George, Utah, 84790, United States

Location

Velicept Investigative Site - West Jordan

West Jordan, Utah, 84088, United States

Location

Velicept Investigative Site - Newport News

Newport News, Virginia, 23606, United States

Location

Velicept Investigative Site - Norfolk

Norfolk, Virginia, 23507, United States

Location

Velicept Investigative Site - Tacoma

Tacoma, Washington, 98405, United States

Location

Velicept Investigative Site - Kenosha

Kenosha, Wisconsin, 53142, United States

Location

Related Publications (1)

• 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.

  PMID: 22695239 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

solabegron

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor representatives Site monitors Data managers Statisticians
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study. Eligible female subjects (N=406) with symptoms of overactive bladder for at least 6 months will enter a 14-day single-blind Run-in Period. Subjects (N=375) who meet prespecified criteria based on data entered into an electronic diary over 3 days will be randomized 1:1:1 (125 subjects per arm) to receive solabegron immediate release tablets, low dose or high dose, or matching placebo.

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 23, 2018
• Study Start: February 19, 2018
• Primary Completion: January 24, 2019
• Study Completion: January 30, 2019
• Last Updated: March 2, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (86)