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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00343486
Recruitment Status : Completed
First Posted : June 23, 2006
Last Update Posted : May 18, 2009
Sponsor:
Information provided by:
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: Solabegron Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : May 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment

Secondary Outcome Measures :
  1. 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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes 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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343486


Locations
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Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline
More Information
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Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00343486    
Other Study ID Numbers: B3P104833
M06-1605.
First Posted: June 23, 2006    Key Record Dates
Last Update Posted: May 18, 2009
Last Verified: May 2009
Keywords provided by GlaxoSmithKline:
Overactive Bladder
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Solabegron
Adrenergic beta-3 Receptor Agonists
 Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs