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

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

Official Title
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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

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: Solabegron


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Solabegron|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive Bladder