Clinical trial NCT00343486: Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-06-23
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment
Secondary outcomes:
measure: 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.
Other outcomes:
Locations:
city: Av Córdoba 2424
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Bahia Blanca
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: GSK Investigational Site
state: Buenos Aires
city: Cordoba
country: Argentina
facility: GSK Investigational Site
state: Córdova
city: Córdoba
country: Argentina
facility: GSK Investigational Site
state: Córdova
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Randwick
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Caboolture
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Kippa Ring
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Carlton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Spring Hill
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Oulu
country: Finland
facility: GSK Investigational Site
city: Tampere
country: Finland
facility: GSK Investigational Site
city: Lyon
country: France
facility: GSK Investigational Site
city: Paris Cedex 12
country: France
facility: GSK Investigational Site
city: Paris Cedex 20
country: France
facility: GSK Investigational Site
city: Saint Genis Laval
country: France
facility: GSK Investigational Site
city: Suresnes
country: France
facility: GSK Investigational Site
city: Hagenow
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Schwedt
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Marburg
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Dessau
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: GSK Investigational Site
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzg
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Apeldoorn
country: Netherlands
facility: GSK Investigational Site
city: Emmen
country: Netherlands
facility: GSK Investigational Site
city: Enschede
country: Netherlands
facility: GSK Investigational Site
city: Nijmegen
country: Netherlands
facility: GSK Investigational Site
city: Tilburg
country: Netherlands
facility: GSK Investigational Site
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
city: Christchurch
country: New Zealand
facility: GSK Investigational Site
city: Dunedin
country: New Zealand
facility: GSK Investigational Site
city: Tauranga
country: New Zealand
facility: GSK Investigational Site
city: Whangarei
country: New Zealand
facility: GSK Investigational Site
city: Lodz
country: Poland
facility: GSK Investigational Site
city: Lublin
country: Poland
facility: GSK Investigational Site
city: Celje
country: Slovenia
facility: GSK Investigational Site
city: Ljubljana
country: Slovenia
facility: GSK Investigational Site
city: Slovenj Gradec
country: Slovenia
facility: GSK Investigational Site
city: Bloemfontein
country: South Africa
facility: GSK Investigational Site
city: Cape Town
country: South Africa
facility: GSK Investigational Site
city: Somerset West
country: South Africa
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Getafe
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: Marbella
country: Spain
facility: GSK Investigational Site
city: San Sebastian
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Vigo (Pontevedra)
country: Spain
facility: GSK Investigational Site
city: Hualien
country: Taiwan
facility: GSK Investigational Site
city: Taichung
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: