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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00343486
First received: June 21, 2006
Last updated: May 15, 2009
Last verified: May 2009
  Purpose

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


Condition Intervention Phase
Overactive Bladder
Drug: Solabegron
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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.

Estimated Enrollment: 240
Study Start Date: May 2006
Intervention Details:
    Drug: Solabegron
    Other Name: Solabegron
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343486

  Hide Study Locations
Locations
Argentina
GSK Investigational Site
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
Cordoba, Córdova, Argentina, 5000
GSK Investigational Site
Córdoba, Córdova, Argentina, 5016
GSK Investigational Site
Buenos Aires, Argentina, C1113AAH
Australia, New South Wales
GSK Investigational Site
Randwick, New South Wales, Australia, 2031
Australia, Queensland
GSK Investigational Site
Caboolture, Queensland, Australia, 4510
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Australia, Victoria
GSK Investigational Site
Carlton, Victoria, Australia, 3053
GSK Investigational Site
Spring Hill, Victoria, Australia, 4000
Finland
GSK Investigational Site
Oulu, Finland, 90100
GSK Investigational Site
Tampere, Finland, 33521
France
GSK Investigational Site
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
Germany
GSK Investigational Site
Hagenow, Brandenburg, Germany, 19230
GSK Investigational Site
Schwedt, Brandenburg, Germany, 16303
GSK Investigational Site
Marburg, Hessen, Germany, 35039
GSK Investigational Site
Dessau, Sachsen-Anhalt, Germany, 06844
GSK Investigational Site
Magdeburg, Sachsen-Anhalt, Germany, 39112
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Leipzg, Sachsen, Germany, 04109
GSK Investigational Site
Leipzig, Sachsen, Germany, 04105
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
GSK Investigational Site
Berlin, Germany, 10787
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Hamburg, Germany, 22143
GSK Investigational Site
Hamburg, Germany, 20249
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
GSK Investigational Site
Seoul, Korea, Republic of, 120-752
GSK Investigational Site
Seoul, Korea, Republic of, 137-701
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
Latvia
GSK Investigational Site
Riga, Latvia, LV 1002
Netherlands
GSK Investigational Site
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
New Zealand
GSK Investigational Site
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
Poland
GSK Investigational Site
Lodz, Poland, 90-710
GSK Investigational Site
Lublin, Poland, 20-954
Slovenia
GSK Investigational Site
Celje, Slovenia, 3000
GSK Investigational Site
Ljubljana, Slovenia, 1000
GSK Investigational Site
Slovenj Gradec, Slovenia, 2380
South Africa
GSK Investigational Site
Bloemfontein, South Africa, 9300
GSK Investigational Site
Cape Town, South Africa, 8001
GSK Investigational Site
Somerset West, South Africa, 7130
Spain
GSK Investigational Site
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
Taiwan
GSK Investigational Site
Hualien, Taiwan, 970
GSK Investigational Site
Taichung, Taiwan, 404
GSK Investigational Site
Taipei, Taiwan, 112
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00343486     History of Changes
Other Study ID Numbers: B3P104833, M06-1605.
Study First Received: June 21, 2006
Last Updated: May 15, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by GlaxoSmithKline:
Overactive Bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solabegron
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 20, 2014