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)

February 27, 2020 updated by: Velicept Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1413

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in mean number of micturitions per 24 hours at Week 12
Time Frame: Micturtions will be assessed prior to randomization and at Week 12 (Visit 6).
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Urinary Incontinence (1)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4 and 8
Change from Baseline in mean number of micturitions per 24 hours
Prior to Randomization (Baseline) and at Weeks 4 and 8
Micturitions (2)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Percentage of subjects with < 8 micturitions per 24 hours
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Micturitions (4)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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)
Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Velicept Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 9, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 2, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 2, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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