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

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

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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT00343486

  Show 66 Study Locations
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

Responsible Party: Study Director, GSK Identifier: NCT00343486     History of Changes
Other Study ID Numbers: B3P104833
Study First Received: June 21, 2006
Last Updated: May 15, 2009

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
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on August 21, 2017