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Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Solabegron immediate release tablets, low dose
Solabegron immediate 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, and urgency urinary 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., Grade 3/4 uterine prolapse, urogenital malignancy within the past 2 years, surgery for stress incontinence or pelvic prolapse repair within the past 6 months, or bladder injections with botulinum toxin at any time.
  • 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 ≥100mmHg, 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 - Gulf Shores
  • Velicept Investigative Site - Mobile
  • Velicept Investigative Site - Tempe
  • Velicept Investigative Site - Tucson
  • Velicept Investigative Site - Little Rock
  • Velicept Investigative Site - Anaheim
  • Velicept Investigative Site - Arcadia
  • Velicept Investigative Site - Canoga Park
  • Velicept Investigative Site - Huntington Beach
  • Velicept Investigative Site - Los Alamitos
  • Velicept Investigative Site - Los Angeles
  • Velicept Investigative Site - Norco
  • Velicept Investigative Site - Sacramento
  • Velicept Investigative Site - San Diego
  • Velicept Investigative Site - San Diego
  • Velicept Investigative Site - San Marcos
  • Velicept Investigative Site - Thousand Oaks
  • Velicept Investigative Site - Denver
  • Velicept Investigative Site - Waterbury
  • Velicept Investigative Site - Clearwater
  • Velicept Investigative Site - Deland
  • Velicept Investigative Site - Doral
  • Velicept Investigative Site - Jupiter
  • Velicept Investigative Site - Lake City
  • Velicept Investigative Site - Miami
  • Velicept Investigative Site - Miami
  • Velicept Investigative Site - Miami
  • Velicept Investigative Site - Ponte Vedra
  • Velicept Investigative Site - Port St Lucie
  • Velicept Investigative Site - West Palm Beach
  • Velicept Investigative Site - Winter Haven
  • Velicept Investigative Site - Marietta
  • Velicept Investigative Site - Blackfoot
  • Velicept Investigative Site - Meridian
  • Velicept Investigative Site - Wauconda
  • Velicept Investigative Site - Elwood
  • Velicept Investigative Site - Evansville
  • Velicept Investigative Site - Newton
  • Velicept Investigative Site - Louisville
  • Velicept Investigative Site - Metairie
  • Velicept Investigative Site - New Orleans
  • Velicept Investigative Site - Shreveport
  • Velicept Investigative Site - Boston
  • Velicept Investigative Site - New Bedford
  • Velicept Investigative Site - North Attleborro
  • Velicept Investigative Site - Watertown
  • Velicept Investigative Site - Kalamazoo
  • Velicept Investigative Site - St. Louis
  • Velicept Investigative Site - Omaha
  • Velicept Investigative Site - Las Vegas
  • Velicept Investigative Site - Brick
  • Velicept Investigative Site - Vorhees
  • Velicept Investigative Site - Albuquerque
  • Velicept Investigative Site - New York
  • Velicept Investigative Site - Williamsville
  • Velicept Investigative Site - Charlotte
  • Velicept Investigative Site - Wilmington
  • Velicept Investigative Site - Winston-Salem
  • Velicept Investigative Site - Cincinnati
  • Velicept Investigative Site - Cleveland
  • Velicept Investigative Site - Columbus
  • Velicept Investigative Site - Marion
  • Velicept Investigative Site - Middleburg Heights
  • Velicept Investigative Site - Warwick
  • Velicept Investigative Site - Mt. Pleasant
  • Velicept Investigative Site - Myrtle Beach
  • Velicept Investigative Site - Jackson
  • Velicept Investigative Site - Knoxville
  • Velicept Investigative Site - Nashville
  • Velicept Investigative Site - Austin
  • Velicept Investigative Site - Beaumont
  • Velicept Investigative Site - Lampasas
  • Velicept Investigative Site - Longview
  • Velicept Investigative Site - San Antonio
  • Velicept Investigative Site - San Antonio
  • Velicept Investigative Site - San Antonio
  • Velicept Investigative Site - Clinton
  • Velicept Investigative Site - St. George
  • Velicept Investigative Site - Salt Lake City
  • Velicept Investigative Site - Salt Lake City
  • Velicept Investigative Site - West Jordan
  • Velicept Investigative Site - Newport News
  • Velicept Investigative Site - Norfolk
  • Velicept Investigative Site - Tacoma
  • Velicept Investigative Site - Kenosha

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Solabegron immediate release tablets low dose

Solabegron immediate release tablets high dose

Placebo Comparator

Arm Description

Outcomes

Primary Outcome Measures

Change from Baseline in mean number of micturitions per 24h 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 24h.
Urinary Incontinence (2)
Percentage change from Baseline in mean number of urgency urinary incontinence episodes per 24h.
Urinary Incontinence (3)
Proportion of subjects with no episodes of urgency urinary incontinence per 24h.
Urinary Incontinence (4)
Proportion of subjects with no episodes of urinary incontinence (urgency or non-urgency) per 24h.
Urinary Incontinence (5)
Change from Baseline in total urinary incontinence episodes (urgency and non-urgency) per 24h.
Micturitions (1)
Change from Baseline in mean number of micturitions per 24h.
Micturitions (2)
Percentage change from Baseline in mean number of micturitions per 24h.
Micturitions (3)
Percentage of subjects with <8 micturitions per 24h.
Micturitions (4)
Change from Baseline in mean number of nocturnal voids per 24h.
Urine Void Volume (1)
Change from Baseline in average void volume over 24h.
Urine Void Volume (2)
Percentage change from Baseline in average void volume over 24h.
Urine Void Volume (3)
Change from Baseline in maximum individual void volume over 24h.
Urine Void Volume (4)
Percentage change from Baseline in maximum individual void volume over 24h.
Urgency (1)
Proportion of subjects with urges with a mean grade of 3 or 4 per 24h.
Urgency (2)
Change from Baseline in urgency assessments per 24h associated with micturitions and incontinence.
Patient Reported Outcomes (1)
Patient Perception of Bladder Condition
Patient Reported Outcomes (2)
Change from Baseline in Symptom Bother Score (OAB-q short form).
Patient Reported Outcomes (3)
Change from Baseline in health-related quality of life (OAB-q short form).

Full Information

First Posted
March 12, 2018
Last Updated
February 27, 2020
Sponsor
Velicept Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03475706
Brief Title
Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women
Official Title
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Oral Solabegron Immediate Release Tablets in the Treatment of Overactive Bladder (OAB) in Adult Female Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
February 19, 2018 (Actual)
Primary Completion Date
January 24, 2019 (Actual)
Study Completion Date
January 30, 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 immediate release low dose or high dose tablets, compared to matched placebo, administered twice 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=406) 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 immediate release tablets, low dose or high dose, or matching placebo.
Masking
ParticipantInvestigator
Masking Description
Sponsor representatives Site monitors Data managers Statisticians
Allocation
Randomized
Enrollment
438 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Solabegron immediate release tablets low dose
Arm Type
Experimental
Arm Title
Solabegron immediate release tablets high dose
Arm Type
Experimental
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Solabegron immediate release tablets, low dose
Intervention Description
twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Solabegron immediate release tablets, high dose
Intervention Description
twice daily for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
twice daily for 12 weeks.
Primary Outcome Measure Information:
Title
Change from Baseline in mean number of micturitions per 24h 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
Micturitions 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 24h.
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 24h.
Time Frame
Prior to Randomization (Baseline) and at Weeks 4 and 8
Title
Urinary Incontinence (3)
Description
Proportion of subjects with no episodes of urgency urinary incontinence per 24h.
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 or non-urgency) per 24h.
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 24h.
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 24h.
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 24h.
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Micturitions (3)
Description
Percentage of subjects with <8 micturitions per 24h.
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 24h.
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 24h.
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 24h.
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 24h.
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 24h.
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 or 4 per 24h.
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Urgency (2)
Description
Change from Baseline in urgency assessments per 24h associated with micturitions and incontinence.
Time Frame
Prior to Randomization (Baseline) and at Weeks 4, 8, and 12
Title
Patient Reported Outcomes (1)
Description
Patient Perception of Bladder Condition
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 (OAB-q short form).
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 (OAB-q short form).
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, and urgency urinary 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., Grade 3/4 uterine prolapse, urogenital malignancy within the past 2 years, surgery for stress incontinence or pelvic prolapse repair within the past 6 months, or bladder injections with botulinum toxin at any time. 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 ≥100mmHg, 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
35205
Country
United States
Facility Name
Velicept Investigative Site - Gulf Shores
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542
Country
United States
Facility Name
Velicept Investigative Site - Mobile
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Velicept Investigative Site - Tempe
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Velicept Investigative Site - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
87504
Country
United States
Facility Name
Velicept Investigative Site - Little Rock
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Velicept Investigative Site - Anaheim
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Velicept Investigative Site - Arcadia
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Velicept Investigative Site - Canoga Park
City
Canoga Park
State/Province
California
ZIP/Postal Code
91303
Country
United States
Facility Name
Velicept Investigative Site - Huntington Beach
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Velicept Investigative Site - Los Alamitos
City
Los Alamitos
State/Province
California
ZIP/Postal Code
90720
Country
United States
Facility Name
Velicept Investigative Site - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Velicept Investigative Site - Norco
City
Norco
State/Province
California
ZIP/Postal Code
92860
Country
United States
Facility Name
Velicept Investigative Site - Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Velicept Investigative Site - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Velicept Investigative Site - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Velicept Investigative Site - San Marcos
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Velicept Investigative Site - Thousand Oaks
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Facility Name
Velicept Investigative Site - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Velicept Investigative Site - Waterbury
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Velicept Investigative Site - Clearwater
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Velicept Investigative Site - Deland
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
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 - Jupiter
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Velicept Investigative Site - Lake City
City
Lake City
State/Province
Florida
ZIP/Postal Code
32055
Country
United States
Facility Name
Velicept Investigative Site - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Velicept Investigative Site - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Velicept Investigative Site - Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Velicept Investigative Site - Ponte Vedra
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
Facility Name
Velicept Investigative Site - Port St Lucie
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
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 - Winter Haven
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Velicept Investigative Site - Marietta
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Velicept Investigative Site - Blackfoot
City
Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
Country
United States
Facility Name
Velicept Investigative Site - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Velicept Investigative Site - Wauconda
City
Wauconda
State/Province
Illinois
ZIP/Postal Code
60084
Country
United States
Facility Name
Velicept Investigative Site - Elwood
City
Elwood
State/Province
Indiana
ZIP/Postal Code
46036
Country
United States
Facility Name
Velicept Investigative Site - Evansville
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Velicept Investigative Site - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Velicept Investigative Site - Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
Velicept Investigative Site - Metairie
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70001
Country
United States
Facility Name
Velicept Investigative Site - New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Velicept Investigative Site - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Velicept Investigative Site - Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Velicept Investigative Site - New Bedford
City
New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
Country
United States
Facility Name
Velicept Investigative Site - North Attleborro
City
North Attleboro
State/Province
Massachusetts
ZIP/Postal Code
02760
Country
United States
Facility Name
Velicept Investigative Site - Watertown
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Velicept Investigative Site - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Velicept Investigative Site - St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Velicept Investigative Site - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Velicept Investigative Site - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Velicept Investigative Site - Brick
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Velicept Investigative Site - Vorhees
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Velicept Investigative Site - Albuquerque
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Velicept Investigative Site - New York
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Velicept Investigative Site - Williamsville
City
Williamsville
State/Province
New York
ZIP/Postal Code
14221
Country
United States
Facility Name
Velicept Investigative Site - Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Velicept Investigative Site - Wilmington
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Velicept Investigative Site - Winston-Salem
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Velicept Investigative Site - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Velicept Investigative Site - Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Velicept Investigative Site - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43123
Country
United States
Facility Name
Velicept Investigative Site - Marion
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Velicept Investigative Site - Middleburg Heights
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
Velicept Investigative Site - Warwick
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02818
Country
United States
Facility Name
Velicept Investigative Site - Mt. Pleasant
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Velicept Investigative Site - Myrtle Beach
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Velicept Investigative Site - Jackson
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Velicept Investigative Site - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Velicept Investigative Site - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Velicept Investigative Site - Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78735
Country
United States
Facility Name
Velicept Investigative Site - Beaumont
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Velicept Investigative Site - Lampasas
City
Lampasas
State/Province
Texas
ZIP/Postal Code
76550
Country
United States
Facility Name
Velicept Investigative Site - Longview
City
Longview
State/Province
Texas
ZIP/Postal Code
80209
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 - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78249
Country
United States
Facility Name
Velicept Investigative Site - Clinton
City
Clinton
State/Province
Utah
ZIP/Postal Code
84015
Country
United States
Facility Name
Velicept Investigative Site - St. George
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States
Facility Name
Velicept Investigative Site - Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Velicept Investigative Site - Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Velicept Investigative Site - West Jordan
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Velicept Investigative Site - Newport News
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Velicept Investigative Site - Norfolk
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Velicept Investigative Site - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Velicept Investigative Site - Kenosha
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
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

Evaluation of the Efficacy and Safety of Solabegron Tablets for Treatment of Overactive Bladder in Adult Women

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