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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)

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Solabegron modified release tablets, low dose
Solabegron modified release tablets, high dose
Matching Placebo
Sponsored by
Velicept Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring overactive bladder, urinary conditions, urgency urinary incontinence, urgency, micturitions

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Velicept Investigative Site - Birmingham
  • Velicept Investigative Site - Birmingham
  • Velicept Investigative Site - Guntersville
  • Velicept Investigative Site - Saraland
  • Velicept Investigative Site - Tucson
  • Velicept Investigative Site - Tucson
  • Velicept Investigative Site - Lincoln
  • Velicept Investigative Site - North Hollywood
  • Velicept Investigative Site - Sacramento
  • Velicept Investigative Site - San Diego
  • Velicept Investigative Site - San Diego
  • Velicept Investigative Site - Spring Valley
  • Velicept Investigative Site - Upland
  • Velicept Investigative Site - Aurora
  • Velicept Investigative Site - Englewood
  • Velicept Investigative Site - New London
  • Velicept Investigative Site - Aventura
  • Velicept Investigative Site - Doral(2)
  • Velicept Investigative Site - Doral
  • Velicept Investigative Site - Edgewater
  • Velicept Investigative Site - Hialeah
  • Velicept Investigative Site - Hollywood
  • Velicept Investigative Site - Lauderdale Lakes
  • Velicept Investigative Site - Miami Springs
  • Velicept Investigative Site - Miami
  • Velicept Investigative Site - Miami
  • Velicept Investigative Site - Miami
  • Velicept Investigative Site - New Port Richey
  • Velicept Investigative Site - Palm Harbor
  • Velicept Investigative Site - Pompano Beach
  • Velicept Investigative Site - Tampa
  • Velicept Investigative Site - West Palm Beach
  • Velicept Investigative Site - Atlanta
  • Velicept Investigative Site - Snellville
  • Velicept Investigative Site - Crowley
  • Velicept Investigative Site - Metairie
  • Velicept Investigative Site - Brighton
  • Velicept Investigative Site - North Dartmouth
  • Velicept Investigative Site - Saginaw
  • Velicept Investigative Site - Biloxi
  • Velicept Investigative Site - Olive Branch
  • Velicept Investigative Site - La Vista
  • Velicept Investigative Site - Las Vegas
  • Velicept Investigative Site - Las Vegas
  • Velicept Investigative Site - Las Vegas
  • Velicept Investigative Site - Edison
  • Velicept Investigative Site - Raleigh
  • Velicept Investigative Site - Fargo
  • Velicept Investigative Site - Dayton
  • Velicept Investigative Site - Mustang
  • Velicept Investigative Site - Oklahoma City
  • Velicept Investigative Site - Gresham
  • Velicept Investigative Site - Lansdale
  • Velicept Investigative Site - East Providence
  • Velicept Investigative Site - Lincoln
  • Velicept Investigative Site - Charleston
  • Velicept Investigative Site - Charleston
  • Velicept Investigative Site - Fort Mill
  • Velicept Investigative Site - Spartanburg
  • Velicept Investigative Site - Chattanooga
  • Velicept Investigative Site - Jackson
  • Velicept Investigative Site - Knoxville
  • Velicept Investigative Site - Austin
  • Velicept Investigative Site - Austin
  • Velicept Investigative Site - Bryan
  • Velicept Investigative Site - Carrollton
  • Velicept Investigative Site - Dallas
  • Velicept Investigative Site - Fort Worth
  • Velicept Investigative Site - Georgetown
  • Velicept Investigative Site - Houston
  • Velicept Investigative Site - Houston
  • Velicept Investigative Site - Plano(1)
  • Velicept Investigative Site - Plano(2)
  • Velicept Investigative Site - San Angelo
  • Velicept Investigative Site - San Antonio
  • Velicept Investigative Site - San Antonio
  • Velicept Investigative Site - Sugar Land

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Solabegron modified release tablets low dose

Solabegron modified release tablets high dose

Placebo Comparator

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Urinary Incontinence (1)
Change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours
Urinary Incontinence (2)
Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours
Urinary Incontinence (3)
Proportion of subjects with no episodes of urgency urinary incontinence per 24 hours
Urinary Incontinence (4)
Proportion of subjects with no episodes of urinary incontinence (urgency and non-urgency) per 24 hours
Urinary Incontinence (5)
Change from Baseline in total urinary incontinence episodes (urgency and non-urgency) per 24 hours
Micturitions (1)
Change from Baseline in mean number of micturitions per 24 hours
Micturitions (2)
Percentage change from Baseline in mean number of micturitions per 24 hours
Micturitions (3)
Percentage of subjects with < 8 micturitions per 24 hours
Micturitions (4)
Change from Baseline in mean number of nocturnal voids per 24 hours
Urine Void Volume (1)
Change from Baseline in average void volume over 24 hours
Urine Void Volume (2)
Percentage change from Baseline in average void volume over 24 hours
Urine Void Volume (3)
Change from Baseline in maximum individual void volume over 24 hours
Urine Void Volume (4)
Percentage change from Baseline in maximum individual void volume over 24 hours
Urgency (1)
Proportion of subjects with urges with a mean grade of 3 of 4 per 24 hours
Urgency (2)
Change from Baseline in mean urgency assessments per 24 hours associated with micturitions or incontinence
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.
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.
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.

Full Information

First Posted
July 9, 2018
Last Updated
February 27, 2020
Sponsor
Velicept Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03594058
Brief Title
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)
Acronym
VEL-2001
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
July 9, 2018 (Actual)
Primary Completion Date
April 29, 2019 (Actual)
Study Completion Date
May 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Velicept Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
overactive bladder, urinary conditions, urgency urinary incontinence, urgency, micturitions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
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
ParticipantInvestigator
Masking Description
Sponsor representatives Site monitors Data managers Statistician
Allocation
Randomized
Enrollment
1413 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solabegron modified release tablets low dose
Arm Type
Experimental
Arm Title
Solabegron modified release tablets high dose
Arm Type
Experimental
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Solabegron modified release tablets, low dose
Intervention Description
Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Solabegron modified release tablets, high dose
Intervention Description
Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.
Primary Outcome Measure Information:
Title
Change from Baseline in mean number of micturitions per 24 hours at Week 12
Description
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.
Time Frame
Micturtions will be assessed prior to randomization and at Week 12 (Visit 6).
Secondary Outcome Measure Information:
Title
Urinary Incontinence (1)
Description
Change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Urinary Incontinence (2)
Description
Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Urinary Incontinence (3)
Description
Proportion of subjects with no episodes of urgency urinary incontinence per 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Urinary Incontinence (4)
Description
Proportion of subjects with no episodes of urinary incontinence (urgency and non-urgency) per 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Urinary Incontinence (5)
Description
Change from Baseline in total urinary incontinence episodes (urgency and non-urgency) per 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Micturitions (1)
Description
Change from Baseline in mean number of micturitions per 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4 and 8
Title
Micturitions (2)
Description
Percentage change from Baseline in mean number of micturitions per 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Micturitions (3)
Description
Percentage of subjects with < 8 micturitions per 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Micturitions (4)
Description
Change from Baseline in mean number of nocturnal voids per 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Urine Void Volume (1)
Description
Change from Baseline in average void volume over 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Urine Void Volume (2)
Description
Percentage change from Baseline in average void volume over 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Urine Void Volume (3)
Description
Change from Baseline in maximum individual void volume over 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Urine Void Volume (4)
Description
Percentage change from Baseline in maximum individual void volume over 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Urgency (1)
Description
Proportion of subjects with urges with a mean grade of 3 of 4 per 24 hours
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Urgency (2)
Description
Change from Baseline in mean urgency assessments per 24 hours associated with micturitions or incontinence
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Patient Reported Outcomes (1)
Description
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.
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Patient Reported Outcomes (2)
Description
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.
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Patient Reported Outcomes (3)
Description
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.
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Velicept Investigative Site - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Velicept Investigative Site - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Velicept Investigative Site - Guntersville
City
Guntersville
State/Province
Alabama
ZIP/Postal Code
35976
Country
United States
Facility Name
Velicept Investigative Site - Saraland
City
Saraland
State/Province
Alabama
ZIP/Postal Code
36571
Country
United States
Facility Name
Velicept Investigative Site - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Velicept Investigative Site - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Velicept Investigative Site - Lincoln
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Velicept Investigative Site - North Hollywood
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Velicept Investigative Site - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95864
Country
United States
Facility Name
Velicept Investigative Site - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Velicept Investigative Site - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92111
Country
United States
Facility Name
Velicept Investigative Site - Spring Valley
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Velicept Investigative Site - Upland
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Velicept Investigative Site - Aurora
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Velicept Investigative Site - Englewood
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Velicept Investigative Site - New London
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Velicept Investigative Site - Aventura
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Velicept Investigative Site - Doral(2)
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Velicept Investigative Site - Doral
City
Doral
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Velicept Investigative Site - Edgewater
City
Edgewater
State/Province
Florida
ZIP/Postal Code
32132
Country
United States
Facility Name
Velicept Investigative Site - Hialeah
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Velicept Investigative Site - Hollywood
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Velicept Investigative Site - Lauderdale Lakes
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Velicept Investigative Site - Miami Springs
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Facility Name
Velicept Investigative Site - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Velicept Investigative Site - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Velicept Investigative Site - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Velicept Investigative Site - New Port Richey
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Velicept Investigative Site - Palm Harbor
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Velicept Investigative Site - Pompano Beach
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Velicept Investigative Site - Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Velicept Investigative Site - West Palm Beach
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Velicept Investigative Site - Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Velicept Investigative Site - Snellville
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Velicept Investigative Site - Crowley
City
Crowley
State/Province
Louisiana
ZIP/Postal Code
70526
Country
United States
Facility Name
Velicept Investigative Site - Metairie
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Velicept Investigative Site - Brighton
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Velicept Investigative Site - North Dartmouth
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Velicept Investigative Site - Saginaw
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48605
Country
United States
Facility Name
Velicept Investigative Site - Biloxi
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531
Country
United States
Facility Name
Velicept Investigative Site - Olive Branch
City
Olive Branch
State/Province
Mississippi
ZIP/Postal Code
38654
Country
United States
Facility Name
Velicept Investigative Site - La Vista
City
La Vista
State/Province
Nebraska
ZIP/Postal Code
68128
Country
United States
Facility Name
Velicept Investigative Site - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Velicept Investigative Site - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
Facility Name
Velicept Investigative Site - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Velicept Investigative Site - Edison
City
Edison
State/Province
New Jersey
ZIP/Postal Code
08837
Country
United States
Facility Name
Velicept Investigative Site - Raleigh
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Velicept Investigative Site - Fargo
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Velicept Investigative Site - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45439
Country
United States
Facility Name
Velicept Investigative Site - Mustang
City
Mustang
State/Province
Oklahoma
ZIP/Postal Code
73064
Country
United States
Facility Name
Velicept Investigative Site - Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Velicept Investigative Site - Gresham
City
Gresham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Velicept Investigative Site - Lansdale
City
Lansdale
State/Province
Pennsylvania
ZIP/Postal Code
19446
Country
United States
Facility Name
Velicept Investigative Site - East Providence
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Velicept Investigative Site - Lincoln
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Velicept Investigative Site - Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Velicept Investigative Site - Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Velicept Investigative Site - Fort Mill
City
Fort Mill
State/Province
South Carolina
ZIP/Postal Code
29707
Country
United States
Facility Name
Velicept Investigative Site - Spartanburg
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29301
Country
United States
Facility Name
Velicept Investigative Site - Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Velicept Investigative Site - Jackson
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38301
Country
United States
Facility Name
Velicept Investigative Site - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37938
Country
United States
Facility Name
Velicept Investigative Site - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Velicept Investigative Site - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Velicept Investigative Site - Bryan
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Velicept Investigative Site - Carrollton
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75010
Country
United States
Facility Name
Velicept Investigative Site - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75224
Country
United States
Facility Name
Velicept Investigative Site - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Velicept Investigative Site - Georgetown
City
Georgetown
State/Province
Texas
ZIP/Postal Code
78626
Country
United States
Facility Name
Velicept Investigative Site - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Velicept Investigative Site - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77082
Country
United States
Facility Name
Velicept Investigative Site - Plano(1)
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Velicept Investigative Site - Plano(2)
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Facility Name
Velicept Investigative Site - San Angelo
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Velicept Investigative Site - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Velicept Investigative Site - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Velicept Investigative Site - Sugar Land
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22695239
Citation
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.
Results Reference
background

Learn more about this trial

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)

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