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)

NCT03594058 | Completed Phase 2 FDA Drug

• 1 other identifier: VEL-2001
• Study Type: interventional
• Target: 1,413
• Locations: 1 country
• Sites: 77

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 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.

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 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 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, 8, and 12

• 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 modified release tablets low dose

EXPERIMENTAL

Drug: Solabegron modified release tablets, low dose

Solabegron modified release tablets high dose

EXPERIMENTAL

Drug: Solabegron modified release tablets, high dose

Placebo Comparator

PLACEBO COMPARATOR

Drug: Matching Placebo

Interventions

Solabegron modified release tablets, low dose DRUG

Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.

Solabegron modified release tablets low dose

Solabegron modified release tablets, high dose DRUG

Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.

Solabegron modified release tablets high dose

Matching Placebo DRUG

Solabegron modified release tablets low dose or high dose or matching placebo once 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, 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

Sponsors & Collaborators

• Velicept Therapeutics, Inc.: lead

Study Sites (77)

Velicept Investigative Site - Birmingham

Birmingham, Alabama, 35209, United States

Location

Velicept Investigative Site - Birmingham

Birmingham, Alabama, 35215, United States

Location

Velicept Investigative Site - Guntersville

Guntersville, Alabama, 35976, United States

Location

Velicept Investigative Site - Saraland

Saraland, Alabama, 36571, United States

Location

Velicept Investigative Site - Tucson

Tucson, Arizona, 85741, United States

Location

Velicept Investigative Site - Tucson

Tucson, Arizona, 85745, United States

Location

Velicept Investigative Site - Lincoln

Lincoln, California, 95648, United States

Location

Velicept Investigative Site - North Hollywood

North Hollywood, California, 91606, United States

Location

Velicept Investigative Site - Sacramento

Sacramento, California, 95864, United States

Location

Velicept Investigative Site - San Diego

San Diego, California, 92108, United States

Location

Velicept Investigative Site - San Diego

San Diego, California, 92111, United States

Location

Velicept Investigative Site - Spring Valley

Spring Valley, California, 91978, United States

Location

Velicept Investigative Site - Upland

Upland, California, 91786, United States

Location

Velicept Investigative Site - Aurora

Aurora, Colorado, 80012, United States

Location

Velicept Investigative Site - Englewood

Englewood, Colorado, 80113, United States

Location

Velicept Investigative Site - New London

New London, Connecticut, 06320, United States

Location

Velicept Investigative Site - Aventura

Aventura, Florida, 33180, United States

Location

Velicept Investigative Site - Doral(2)

Doral, Florida, 33166, United States

Location

Velicept Investigative Site - Doral

Doral, Florida, 33166, United States

Location

Velicept Investigative Site - Edgewater

Edgewater, Florida, 32132, United States

Location

Velicept Investigative Site - Hialeah

Hialeah, Florida, 33012, United States

Location

Velicept Investigative Site - Hollywood

Hollywood, Florida, 33024, United States

Location

Velicept Investigative Site - Lauderdale Lakes

Lauderdale Lakes, Florida, 33319, United States

Location

Velicept Investigative Site - Miami

Miami, Florida, 33015, United States

Location

Velicept Investigative Site - Miami

Miami, Florida, 33144, United States

Location

Velicept Investigative Site - Miami

Miami, Florida, 33155, United States

Location

Velicept Investigative Site - Miami Springs

Miami Springs, Florida, 33166, United States

Location

Velicept Investigative Site - New Port Richey

New Port Richey, Florida, 34653, United States

Location

Velicept Investigative Site - Palm Harbor

Palm Harbor, Florida, 34684, United States

Location

Velicept Investigative Site - Pompano Beach

Pompano Beach, Florida, 33060, United States

Location

Velicept Investigative Site - Tampa

Tampa, Florida, 33615, United States

Location

Velicept Investigative Site - West Palm Beach

West Palm Beach, Florida, 33409, United States

Location

Velicept Investigative Site - Atlanta

Atlanta, Georgia, 30328, United States

Location

Velicept Investigative Site - Snellville

Snellville, Georgia, 30078, United States

Location

Velicept Investigative Site - Crowley

Crowley, Louisiana, 70526, United States

Location

Velicept Investigative Site - Metairie

Metairie, Louisiana, 70006, United States

Location

Velicept Investigative Site - Brighton

Brighton, Massachusetts, 02135, United States

Location

Velicept Investigative Site - North Dartmouth

North Dartmouth, Massachusetts, 02747, United States

Location

Velicept Investigative Site - Saginaw

Saginaw, Michigan, 48605, United States

Location

Velicept Investigative Site - Biloxi

Biloxi, Mississippi, 39531, United States

Location

Velicept Investigative Site - Olive Branch

Olive Branch, Mississippi, 38654, United States

Location

Velicept Investigative Site - La Vista

La Vista, Nebraska, 68128, United States

Location

Velicept Investigative Site - Las Vegas

Las Vegas, Nevada, 89109, United States

Location

Velicept Investigative Site - Las Vegas

Las Vegas, Nevada, 89117, United States

Location

Velicept Investigative Site - Las Vegas

Las Vegas, Nevada, 89128, United States

Location

Velicept Investigative Site - Edison

Edison, New Jersey, 08837, United States

Location

Velicept Investigative Site - Raleigh

Raleigh, North Carolina, 27612, United States

Location

Velicept Investigative Site - Fargo

Fargo, North Dakota, 58103, United States

Location

Velicept Investigative Site - Dayton

Dayton, Ohio, 45439, United States

Location

Velicept Investigative Site - Mustang

Mustang, Oklahoma, 73064, United States

Location

Velicept Investigative Site - Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

Location

Velicept Investigative Site - Gresham

Gresham, Oregon, 97030, United States

Location

Velicept Investigative Site - Lansdale

Lansdale, Pennsylvania, 19446, United States

Location

Velicept Investigative Site - East Providence

East Providence, Rhode Island, 02914, United States

Location

Velicept Investigative Site - Lincoln

Lincoln, Rhode Island, 02865, United States

Location

Velicept Investigative Site - Charleston

Charleston, South Carolina, 29406, United States

Location

Velicept Investigative Site - Charleston

Charleston, South Carolina, 29407, United States

Location

Velicept Investigative Site - Fort Mill

Fort Mill, South Carolina, 29707, United States

Location

Velicept Investigative Site - Spartanburg

Spartanburg, South Carolina, 29301, United States

Location

Velicept Investigative Site - Chattanooga

Chattanooga, Tennessee, 37421, United States

Location

Velicept Investigative Site - Jackson

Jackson, Tennessee, 38301, United States

Location

Velicept Investigative Site - Knoxville

Knoxville, Tennessee, 37938, United States

Location

Velicept Investigative Site - Austin

Austin, Texas, 78704, United States

Location

Velicept Investigative Site - Austin

Austin, Texas, 78705, United States

Location

Velicept Investigative Site - Bryan

Bryan, Texas, 77802, United States

Location

Velicept Investigative Site - Carrollton

Carrollton, Texas, 75010, United States

Location

Velicept Investigative Site - Dallas

Dallas, Texas, 75224, United States

Location

Velicept Investigative Site - Fort Worth

Fort Worth, Texas, 76135, United States

Location

Velicept Investigative Site - Georgetown

Georgetown, Texas, 78626, United States

Location

Velicept Investigative Site - Houston

Houston, Texas, 77030, United States

Location

Velicept Investigative Site - Houston

Houston, Texas, 77082, United States

Location

Velicept Investigative Site - Plano(1)

Plano, Texas, 75024, United States

Location

Velicept Investigative Site - Plano(2)

Plano, Texas, 75024, United States

Location

Velicept Investigative Site - San Angelo

San Angelo, Texas, 76904, 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 - Sugar Land

Sugar Land, Texas, 77478, 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

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 Statistician
• 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=1200) 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 modified release tablets, low dose or high dose, or matching placebo.

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 20, 2018
• Study Start: July 9, 2018
• Primary Completion: April 29, 2019
• Study Completion: May 2, 2019
• Last Updated: March 2, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (77)