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Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Solabegron
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder

Eligibility Criteria

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

Inclusion Criteria: Overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain. Body mass index in the range of = 19 kg/m2 to <35 kg/m2. Exclusion Criteria: Pregnant Of childbearing potential or willing to use specific barrier methods outlined in the protocol. Grade III/IV pelvic organ prolapse with or without cystocele. History of interstitial cystitis or bladder related pain. Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history. History of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within six months of screening. Urinary incontinence due to causes other then detrusor over activity (e.g., overflow incontinence). Nocturnal enuresis only. Urinary retention, or other evidence of poor detrusor function. Current or history of Urinary Tract Infection. Diabetes insipidus. History of myocardial infarction, unstable angina, or Congestive heart failure. Chronic severe constipation. History of prior anti-incontinence surgery. History of radiation cystitis or a history of pelvic irradiation. Electrostimulation, biofeedback, or bladder training therapy (behavioral therapy) during the previous month prior to screening, or the intention to initiate such therapies during the study. Pessaries and implants are also excluded. Received any investigational product within 30 days of enrollment into the study.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
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  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment

Secondary Outcome Measures

Improvement overactive bladder symptoms per 24 hrs after 4 and 8 weeks of treatment. Improvement in health related Qol. Descriptive statistics of solabegron and it's primary metabolite.

Full Information

First Posted
June 21, 2006
Last Updated
May 15, 2009
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00343486
Brief Title
Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms
Official Title
An Eight- Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as Well as the Pharmacokinetic Profile of Oral Solabegron (GW427353) 125mg and 50mg Administered Twice Daily vs Placebo in Women With Overactive Bladder
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GlaxoSmithKline

4. Oversight

5. Study Description

Brief Summary
This study will test the effectiveness and safety of two doses of solabegron against placebo in reducing the symptoms of overactive bladder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
240 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Solabegron
Primary Outcome Measure Information:
Title
Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment
Secondary Outcome Measure Information:
Title
Improvement overactive bladder symptoms per 24 hrs after 4 and 8 weeks of treatment. Improvement in health related Qol. Descriptive statistics of solabegron and it's primary metabolite.

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: Overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain. Body mass index in the range of = 19 kg/m2 to <35 kg/m2. Exclusion Criteria: Pregnant Of childbearing potential or willing to use specific barrier methods outlined in the protocol. Grade III/IV pelvic organ prolapse with or without cystocele. History of interstitial cystitis or bladder related pain. Stress incontinence or mixed incontinence where stress incontinence is the predominant component based on prior history. History of pelvic prolapse repair (cystocele or rectocele) or urethral diverticulectomy within six months of screening. Urinary incontinence due to causes other then detrusor over activity (e.g., overflow incontinence). Nocturnal enuresis only. Urinary retention, or other evidence of poor detrusor function. Current or history of Urinary Tract Infection. Diabetes insipidus. History of myocardial infarction, unstable angina, or Congestive heart failure. Chronic severe constipation. History of prior anti-incontinence surgery. History of radiation cystitis or a history of pelvic irradiation. Electrostimulation, biofeedback, or bladder training therapy (behavioral therapy) during the previous month prior to screening, or the intention to initiate such therapies during the study. Pessaries and implants are also excluded. Received any investigational product within 30 days of enrollment into the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Av Córdoba 2424
State/Province
Buenos Aires
ZIP/Postal Code
1120
Country
Argentina
Facility Name
GSK Investigational Site
City
Bahia Blanca
State/Province
Buenos Aires
ZIP/Postal Code
8001
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1406CPC
Country
Argentina
Facility Name
GSK Investigational Site
City
Ciudad de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1425BGV
Country
Argentina
Facility Name
GSK Investigational Site
City
Cordoba
State/Province
Córdova
ZIP/Postal Code
5000
Country
Argentina
Facility Name
GSK Investigational Site
City
Córdoba
State/Province
Córdova
ZIP/Postal Code
5016
Country
Argentina
Facility Name
GSK Investigational Site
City
Buenos Aires
ZIP/Postal Code
C1113AAH
Country
Argentina
Facility Name
GSK Investigational Site
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
GSK Investigational Site
City
Caboolture
State/Province
Queensland
ZIP/Postal Code
4510
Country
Australia
Facility Name
GSK Investigational Site
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
GSK Investigational Site
City
Carlton
State/Province
Victoria
ZIP/Postal Code
3053
Country
Australia
Facility Name
GSK Investigational Site
City
Spring Hill
State/Province
Victoria
ZIP/Postal Code
4000
Country
Australia
Facility Name
GSK Investigational Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
GSK Investigational Site
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Facility Name
GSK Investigational Site
City
Lyon
ZIP/Postal Code
69437
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 20
ZIP/Postal Code
75970
Country
France
Facility Name
GSK Investigational Site
City
Saint Genis Laval
ZIP/Postal Code
69230
Country
France
Facility Name
GSK Investigational Site
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
GSK Investigational Site
City
Hagenow
State/Province
Brandenburg
ZIP/Postal Code
19230
Country
Germany
Facility Name
GSK Investigational Site
City
Schwedt
State/Province
Brandenburg
ZIP/Postal Code
16303
Country
Germany
Facility Name
GSK Investigational Site
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35039
Country
Germany
Facility Name
GSK Investigational Site
City
Dessau
State/Province
Sachsen-Anhalt
ZIP/Postal Code
06844
Country
Germany
Facility Name
GSK Investigational Site
City
Magdeburg
State/Province
Sachsen-Anhalt
ZIP/Postal Code
39112
Country
Germany
Facility Name
GSK Investigational Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzg
State/Province
Sachsen
ZIP/Postal Code
04109
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
GSK Investigational Site
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04105
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20249
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
22143
Country
Germany
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
GSK Investigational Site
City
Riga
ZIP/Postal Code
LV 1002
Country
Latvia
Facility Name
GSK Investigational Site
City
Apeldoorn
ZIP/Postal Code
7314 ET
Country
Netherlands
Facility Name
GSK Investigational Site
City
Emmen
ZIP/Postal Code
7824 AA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Enschede
ZIP/Postal Code
7511JX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Tilburg
ZIP/Postal Code
5022 GC
Country
Netherlands
Facility Name
GSK Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CJ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Christchurch
ZIP/Postal Code
8014
Country
New Zealand
Facility Name
GSK Investigational Site
City
Dunedin
ZIP/Postal Code
9016
Country
New Zealand
Facility Name
GSK Investigational Site
City
Tauranga
ZIP/Postal Code
3140
Country
New Zealand
Facility Name
GSK Investigational Site
City
Whangarei
ZIP/Postal Code
0112
Country
New Zealand
Facility Name
GSK Investigational Site
City
Lodz
ZIP/Postal Code
90-710
Country
Poland
Facility Name
GSK Investigational Site
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
GSK Investigational Site
City
Celje
ZIP/Postal Code
3000
Country
Slovenia
Facility Name
GSK Investigational Site
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
GSK Investigational Site
City
Slovenj Gradec
ZIP/Postal Code
2380
Country
Slovenia
Facility Name
GSK Investigational Site
City
Bloemfontein
ZIP/Postal Code
9300
Country
South Africa
Facility Name
GSK Investigational Site
City
Cape Town
ZIP/Postal Code
8001
Country
South Africa
Facility Name
GSK Investigational Site
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
GSK Investigational Site
City
Getafe
ZIP/Postal Code
28905
Country
Spain
Facility Name
GSK Investigational Site
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
GSK Investigational Site
City
Marbella
ZIP/Postal Code
29600
Country
Spain
Facility Name
GSK Investigational Site
City
San Sebastian
ZIP/Postal Code
20014
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
GSK Investigational Site
City
Vigo (Pontevedra)
ZIP/Postal Code
30211
Country
Spain
Facility Name
GSK Investigational Site
City
Hualien
ZIP/Postal Code
970
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
GSK Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms

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