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

May 15, 2009 updated by: GlaxoSmithKline

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1113AAH
        • GSK Investigational Site
    • Buenos Aires
      • Av Córdoba 2424, Buenos Aires, Argentina, 1120
        • GSK Investigational Site
      • Bahia Blanca, Buenos Aires, Argentina, 8001
        • GSK Investigational Site
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1406CPC
        • GSK Investigational Site
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1425BGV
        • GSK Investigational Site
    • Córdova
      • Cordoba, Córdova, Argentina, 5000
        • GSK Investigational Site
      • Córdoba, Córdova, Argentina, 5016
        • GSK Investigational Site
  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • GSK Investigational Site
    • Queensland
      • Caboolture, Queensland, Australia, 4510
        • GSK Investigational Site
      • Kippa Ring, Queensland, Australia, 4021
        • GSK Investigational Site
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • GSK Investigational Site
      • Spring Hill, Victoria, Australia, 4000
        • GSK Investigational Site
  • Finland
      • Oulu, Finland, 90100
        • GSK Investigational Site
      • Tampere, Finland, 33521
        • GSK Investigational Site
  • France
      • Lyon, France, 69437
        • GSK Investigational Site
      • Paris Cedex 12, France, 75571
        • GSK Investigational Site
      • Paris Cedex 20, France, 75970
        • GSK Investigational Site
      • Saint Genis Laval, France, 69230
        • GSK Investigational Site
      • Suresnes, France, 92151
        • GSK Investigational Site
  • Germany
      • Berlin, Germany, 13125
        • GSK Investigational Site
      • Berlin, Germany, 10787
        • GSK Investigational Site
      • Hamburg, Germany, 22143
        • GSK Investigational Site
      • Hamburg, Germany, 20249
        • GSK Investigational Site
    • Brandenburg
      • Hagenow, Brandenburg, Germany, 19230
        • GSK Investigational Site
      • Schwedt, Brandenburg, Germany, 16303
        • GSK Investigational Site
    • Hessen
      • Marburg, Hessen, Germany, 35039
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • GSK Investigational Site
      • Leipzg, Sachsen, Germany, 04109
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04103
        • GSK Investigational Site
      • Leipzig, Sachsen, Germany, 04105
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Dessau, Sachsen-Anhalt, Germany, 06844
        • GSK Investigational Site
      • Magdeburg, Sachsen-Anhalt, Germany, 39112
        • GSK Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 138-736
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 137-701
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 135-710
        • GSK Investigational Site
  • Latvia
      • Riga, Latvia, LV 1002
        • GSK Investigational Site
  • Netherlands
      • Apeldoorn, Netherlands, 7314 ET
        • GSK Investigational Site
      • Emmen, Netherlands, 7824 AA
        • GSK Investigational Site
      • Enschede, Netherlands, 7511JX
        • GSK Investigational Site
      • Nijmegen, Netherlands, 6525 GA
        • GSK Investigational Site
      • Tilburg, Netherlands, 5022 GC
        • GSK Investigational Site
      • Utrecht, Netherlands, 3584 CJ
        • GSK Investigational Site
  • New Zealand
      • Christchurch, New Zealand, 8014
        • GSK Investigational Site
      • Dunedin, New Zealand, 9016
        • GSK Investigational Site
      • Tauranga, New Zealand, 3140
        • GSK Investigational Site
      • Whangarei, New Zealand, 0112
        • GSK Investigational Site
  • Poland
      • Lodz, Poland, 90-710
        • GSK Investigational Site
      • Lublin, Poland, 20-954
        • GSK Investigational Site
  • Slovenia
      • Celje, Slovenia, 3000
        • GSK Investigational Site
      • Ljubljana, Slovenia, 1000
        • GSK Investigational Site
      • Slovenj Gradec, Slovenia, 2380
        • GSK Investigational Site
  • South Africa
      • Bloemfontein, South Africa, 9300
        • GSK Investigational Site
      • Cape Town, South Africa, 8001
        • GSK Investigational Site
      • Somerset West, South Africa, 7130
        • GSK Investigational Site
  • Spain
      • Barcelona, Spain, 08035
        • GSK Investigational Site
      • Getafe, Spain, 28905
        • GSK Investigational Site
      • Granada, Spain, 18012
        • GSK Investigational Site
      • Marbella, Spain, 29600
        • GSK Investigational Site
      • San Sebastian, Spain, 20014
        • GSK Investigational Site
      • Valencia, Spain, 46010
        • GSK Investigational Site
      • Valencia, Spain, 46009
        • GSK Investigational Site
      • Vigo (Pontevedra), Spain, 30211
        • GSK Investigational Site
  • Taiwan
      • Hualien, Taiwan, 970
        • GSK Investigational Site
      • Taichung, Taiwan, 404
        • GSK Investigational Site
      • Taipei, Taiwan, 112
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Registration Dates

First Submitted

June 21, 2006

First Submitted That Met QC Criteria

June 21, 2006

First Posted (Estimate)

June 23, 2006

Study Record Updates

Last Update Posted (Estimate)

May 18, 2009

Last Update Submitted That Met QC Criteria

May 15, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3P104833
  • M06-1605.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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