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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)

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ClinicalTrials.gov Identifier: NCT03594058
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : March 2, 2020
Sponsor:
Information provided by (Responsible Party):
Velicept Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Solabegron modified release tablets, low dose Drug: Solabegron modified release tablets, high dose Drug: Matching Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Investigator)
Masking Description: Sponsor representatives Site monitors Data managers Statistician
Primary Purpose: Treatment
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
Actual Study Start Date : July 9, 2018
Actual Primary Completion Date : April 29, 2019
Actual Study Completion Date : May 2, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
Placebo Comparator: Placebo Comparator Drug: Matching Placebo
Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Micturitions (3) [ Time Frame: Prior to Randomization (Baseline) and at Weeks 4, 8, and 12 ]
    Percentage of subjects with < 8 micturitions per 24 hours

  9. 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

  10. 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

  11. 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

  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

  13. 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

  14. 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

  15. 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

  16. 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.

  17. 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.

  18. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594058


Locations
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Sponsors and Collaborators
Velicept Therapeutics, Inc.
More Information
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Publications:

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Responsible Party: Velicept Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03594058    
Other Study ID Numbers: VEL-2001
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: March 2, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Velicept Therapeutics, Inc.:
overactive bladder
urinary conditions
urgency urinary incontinence
urgency
micturitions
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Solabegron
Adrenergic beta-3 Receptor Agonists
 Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs