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

NCT ID: NCT00343486

Last Updated: 2009-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

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.

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Detailed Description

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Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Solabegron

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Av Córdoba 2424, Buenos Aires, Argentina

Site Status

GSK Investigational Site

Bahía Blanca, Buenos Aires, Argentina

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GSK Investigational Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

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GSK Investigational Site

Ciudad de Buenos Aires, Buenos Aires, Argentina

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GSK Investigational Site

Córdoba, Córdoba Province, Argentina

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Córdoba, Córdoba Province, Argentina

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GSK Investigational Site

Buenos Aires, , Argentina

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Randwick, New South Wales, Australia

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Caboolture, Queensland, Australia

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Kippa-Ring, Queensland, Australia

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Carlton, Victoria, Australia

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Spring Hill, Victoria, Australia

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Oulu, , Finland

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Tampere, , Finland

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Lyon, , France

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Paris, , France

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Paris, , France

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Saint-Genis-Laval, , France

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Suresnes, , France

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Hagenow, Brandenburg, Germany

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Schwedt, Brandenburg, Germany

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Hamburg, City state of Hamburg, Germany

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Hamburg, City state of Hamburg, Germany

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Marburg, Hesse, Germany

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Dresden, Saxony, Germany

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Leipzg, Saxony, Germany

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Leipzig, Saxony, Germany

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Leipzig, Saxony, Germany

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Dessau, Saxony-Anhalt, Germany

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Magdeburg, Saxony-Anhalt, Germany

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Berlin, State of Berlin, Germany

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Berlin, State of Berlin, Germany

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Riga, , Latvia

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Apeldoorn, , Netherlands

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Emmen, , Netherlands

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Enschede, , Netherlands

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Nijmegen, , Netherlands

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Tilburg, , Netherlands

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Utrecht, , Netherlands

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Christchurch, , New Zealand

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Dunedin, , New Zealand

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Tauranga, , New Zealand

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Whangarei, , New Zealand

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Lodz, , Poland

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Lublin, , Poland

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Celje, , Slovenia

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Ljubljana, , Slovenia

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Slovenj Gradec, , Slovenia

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Somerset West, , South Africa

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Barcelona, , Spain

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Donostia / San Sebastian, , Spain

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Getafe, , Spain

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Granada, , Spain

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Marbella, , Spain

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GSK Investigational Site

Valencia, , Spain

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Valencia, , Spain

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GSK Investigational Site

Vigo (Pontevedra), , Spain

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GSK Investigational Site

Hualien City, , Taiwan

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GSK Investigational Site

Taichung, , Taiwan

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GSK Investigational Site

Taipei, , Taiwan

Site Status

Countries

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Argentina Australia Finland France Germany Latvia Netherlands New Zealand Poland Slovenia South Africa South Korea Spain Taiwan

Other Identifiers

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M06-1605.

Identifier Type: -

Identifier Source: secondary_id

B3P104833

Identifier Type: -

Identifier Source: org_study_id

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