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Overactive BladderPhase 2VEL-2001NCT03594058

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)

A Phase 2 study testing Solabegron modified release tablets, low dose and Solabegron modified release tablets, high dose in people with Overactive Bladder, run by Velicept Therapeutics, Inc. at 77 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Overactive Bladder
What is being tested?
Solabegron modified release tablets, low dose and Solabegron modified release tablets, high dose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,413 participants
Where
77 sitesUnited States
Study dates
9 Jul 2018to 2 May 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

77 sites in 1 country.

77 sites in 1 country

United States77 sites

  • Velicept Investigative Site - Atlanta

    Atlanta, Georgia, 30328

  • Velicept Investigative Site - Aurora

    Aurora, Colorado, 80012

  • Velicept Investigative Site - Austin

    Austin, Texas, 78704

  • Velicept Investigative Site - Austin

    Austin, Texas, 78705

  • Velicept Investigative Site - Aventura

    Aventura, Florida, 33180

  • Velicept Investigative Site - Biloxi

    Biloxi, Mississippi, 39531

  • Velicept Investigative Site - Birmingham

    Birmingham, Alabama, 35209

  • Velicept Investigative Site - Birmingham

    Birmingham, Alabama, 35215

  • Velicept Investigative Site - Brighton

    Brighton, Massachusetts, 02135

  • Velicept Investigative Site - Bryan

    Bryan, Texas, 77802

  • Velicept Investigative Site - Carrollton

    Carrollton, Texas, 75010

  • Velicept Investigative Site - Charleston

    Charleston, South Carolina, 29406

  • Velicept Investigative Site - Charleston

    Charleston, South Carolina, 29407

  • Velicept Investigative Site - Chattanooga

    Chattanooga, Tennessee, 37421

  • Velicept Investigative Site - Crowley

    Crowley, Louisiana, 70526

  • Velicept Investigative Site - Dallas

    Dallas, Texas, 75224

  • Velicept Investigative Site - Dayton

    Dayton, Ohio, 45439

  • Velicept Investigative Site - Doral(2)

    Doral, Florida, 33166

  • Velicept Investigative Site - Doral

    Doral, Florida, 33166

  • Velicept Investigative Site - East Providence

    East Providence, Rhode Island, 02914

  • Velicept Investigative Site - Edgewater

    Edgewater, Florida, 32132

  • Velicept Investigative Site - Edison

    Edison, New Jersey, 08837

  • Velicept Investigative Site - Englewood

    Englewood, Colorado, 80113

  • Velicept Investigative Site - Fargo

    Fargo, North Dakota, 58103

  • Velicept Investigative Site - Fort Mill

    Fort Mill, South Carolina, 29707

  • Velicept Investigative Site - Fort Worth

    Fort Worth, Texas, 76135

  • Velicept Investigative Site - Georgetown

    Georgetown, Texas, 78626

  • Velicept Investigative Site - Gresham

    Gresham, Oregon, 97030

  • Velicept Investigative Site - Guntersville

    Guntersville, Alabama, 35976

  • Velicept Investigative Site - Hialeah

    Hialeah, Florida, 33012

  • Velicept Investigative Site - Hollywood

    Hollywood, Florida, 33024

  • Velicept Investigative Site - Houston

    Houston, Texas, 77030

  • Velicept Investigative Site - Houston

    Houston, Texas, 77082

  • Velicept Investigative Site - Jackson

    Jackson, Tennessee, 38301

  • Velicept Investigative Site - Knoxville

    Knoxville, Tennessee, 37938

  • Velicept Investigative Site - La Vista

    La Vista, Nebraska, 68128

  • Velicept Investigative Site - Lansdale

    Lansdale, Pennsylvania, 19446

  • Velicept Investigative Site - Las Vegas

    Las Vegas, Nevada, 89109

  • Velicept Investigative Site - Las Vegas

    Las Vegas, Nevada, 89117

  • Velicept Investigative Site - Las Vegas

    Las Vegas, Nevada, 89128

  • Velicept Investigative Site - Lauderdale Lakes

    Lauderdale Lakes, Florida, 33319

  • Velicept Investigative Site - Lincoln

    Lincoln, California, 95648

  • Velicept Investigative Site - Lincoln

    Lincoln, Rhode Island, 02865

  • Velicept Investigative Site - Metairie

    Metairie, Louisiana, 70006

  • Velicept Investigative Site - Miami

    Miami, Florida, 33015

  • Velicept Investigative Site - Miami

    Miami, Florida, 33144

  • Velicept Investigative Site - Miami

    Miami, Florida, 33155

  • Velicept Investigative Site - Miami Springs

    Miami Springs, Florida, 33166

  • Velicept Investigative Site - Mustang

    Mustang, Oklahoma, 73064

  • Velicept Investigative Site - New London

    New London, Connecticut, 06320

  • Velicept Investigative Site - New Port Richey

    New Port Richey, Florida, 34653

  • Velicept Investigative Site - North Dartmouth

    North Dartmouth, Massachusetts, 02747

  • Velicept Investigative Site - North Hollywood

    North Hollywood, California, 91606

  • Velicept Investigative Site - Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Velicept Investigative Site - Olive Branch

    Olive Branch, Mississippi, 38654

  • Velicept Investigative Site - Palm Harbor

    Palm Harbor, Florida, 34684

  • Velicept Investigative Site - Plano(1)

    Plano, Texas, 75024

  • Velicept Investigative Site - Plano(2)

    Plano, Texas, 75024

  • Velicept Investigative Site - Pompano Beach

    Pompano Beach, Florida, 33060

  • Velicept Investigative Site - Raleigh

    Raleigh, North Carolina, 27612

  • Velicept Investigative Site - Sacramento

    Sacramento, California, 95864

  • Velicept Investigative Site - Saginaw

    Saginaw, Michigan, 48605

  • Velicept Investigative Site - San Angelo

    San Angelo, Texas, 76904

  • Velicept Investigative Site - San Antonio

    San Antonio, Texas, 78209

  • Velicept Investigative Site - San Antonio

    San Antonio, Texas, 78229

  • Velicept Investigative Site - San Diego

    San Diego, California, 92108

  • Velicept Investigative Site - San Diego

    San Diego, California, 92111

  • Velicept Investigative Site - Saraland

    Saraland, Alabama, 36571

  • Velicept Investigative Site - Snellville

    Snellville, Georgia, 30078

  • Velicept Investigative Site - Spartanburg

    Spartanburg, South Carolina, 29301

  • Velicept Investigative Site - Spring Valley

    Spring Valley, California, 91978

  • Velicept Investigative Site - Sugar Land

    Sugar Land, Texas, 77478

  • Velicept Investigative Site - Tampa

    Tampa, Florida, 33615

  • Velicept Investigative Site - Tucson

    Tucson, Arizona, 85741

  • Velicept Investigative Site - Tucson

    Tucson, Arizona, 85745

  • Velicept Investigative Site - Upland

    Upland, California, 91786

  • Velicept Investigative Site - West Palm Beach

    West Palm Beach, Florida, 33409

Other trials in United States

About this study

Official title: 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.

Being tested
Solabegron modified release tablets, low dose, Solabegron modified release tablets, high dose, Matching Placebo
Keywords
overactive bladder, urinary conditions, urgency urinary incontinence, urgency, micturitions
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Solabegron modified release tablets, low doseDrug

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

  • Solabegron modified release tablets, high doseDrug

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

  • Matching PlaceboDrug

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

Study groups in NCT03594058
Study groupRoleWhat they receive
Solabegron modified release tablets low doseExperimentalNot described
Receives: Drug: Solabegron modified release tablets, low dose
Solabegron modified release tablets high doseExperimentalNot described
Receives: Drug: Solabegron modified release tablets, high dose
Placebo ComparatorPlacebo comparatorNot described
Receives: Drug: Matching Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Micturtions will be assessed prior to randomization and at Week 12 (Visit 6).

Secondary outcomes (18)

  1. Urinary Incontinence (1)

    Change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours

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

  2. Urinary Incontinence (2)

    Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours

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

  3. Urinary Incontinence (3)

    Proportion of subjects with no episodes of urgency urinary incontinence per 24 hours

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

  4. Urinary Incontinence (4)

    Proportion of subjects with no episodes of urinary incontinence (urgency and non-urgency) per 24 hours

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

  5. Urinary Incontinence (5)

    Change from Baseline in total urinary incontinence episodes (urgency and non-urgency) per 24 hours

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

  6. Micturitions (1)

    Change from Baseline in mean number of micturitions per 24 hours

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

  7. Micturitions (2)

    Percentage change from Baseline in mean number of micturitions per 24 hours

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

  8. Micturitions (3)

    Percentage of subjects with < 8 micturitions per 24 hours

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

  9. Micturitions (4)

    Change from Baseline in mean number of nocturnal voids per 24 hours

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

  10. Urine Void Volume (1)

    Change from Baseline in average void volume over 24 hours

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

  11. Urine Void Volume (2)

    Percentage change from Baseline in average void volume over 24 hours

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

  12. Urine Void Volume (3)

    Change from Baseline in maximum individual void volume over 24 hours

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

  13. Urine Void Volume (4)

    Percentage change from Baseline in maximum individual void volume over 24 hours

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

  14. Urgency (1)

    Proportion of subjects with urges with a mean grade of 3 of 4 per 24 hours

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

  15. Urgency (2)

    Change from Baseline in mean urgency assessments per 24 hours associated with micturitions or incontinence

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

  16. 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.

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

  17. 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.

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

  18. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2018
  2. Study start9 Jul 2018
  3. Primary completion29 Apr 2019
  4. Study completion2 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03594058
Sponsor's protocol ID
VEL-2001
Acronym
VEL-2001
Status last verified
Aug 2019
First submitted
9 Jul 2018
Last updated
2 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 22695239

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Solabegron modified release tablets, low dose and Solabegron modified release tablets, high dose in people with Overactive Bladder, run by Velicept Therapeutics, Inc. at 77 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03594058, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020.

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