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

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00343486
• Other study ID #: B3P104833
• Secondary ID: M06-1605.
• Status: Completed
• Phase: Phase 2
• First received: June 21, 2006
• Last updated: May 15, 2009
• Start date: May 2006

Study information

• Verified date: May 2009
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Solabegron

Locations

Country	Name	City	State
Argentina	GSK Investigational Site	Av Córdoba 2424	Buenos Aires
Argentina	GSK Investigational Site	Bahia Blanca	Buenos Aires
Argentina	GSK Investigational Site	Buenos Aires
Argentina	GSK Investigational Site	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Ciudad de Buenos Aires	Buenos Aires
Argentina	GSK Investigational Site	Cordoba	Córdova
Argentina	GSK Investigational Site	Córdoba	Córdova
Australia	GSK Investigational Site	Caboolture	Queensland
Australia	GSK Investigational Site	Carlton	Victoria
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	GSK Investigational Site	Randwick	New South Wales
Australia	GSK Investigational Site	Spring Hill	Victoria
Finland	GSK Investigational Site	Oulu
Finland	GSK Investigational Site	Tampere
France	GSK Investigational Site	Lyon
France	GSK Investigational Site	Paris Cedex 12
France	GSK Investigational Site	Paris Cedex 20
France	GSK Investigational Site	Saint Genis Laval
France	GSK Investigational Site	Suresnes
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Dessau	Sachsen-Anhalt
Germany	GSK Investigational Site	Dresden	Sachsen
Germany	GSK Investigational Site	Hagenow	Brandenburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Leipzg	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Leipzig	Sachsen
Germany	GSK Investigational Site	Magdeburg	Sachsen-Anhalt
Germany	GSK Investigational Site	Marburg	Hessen
Germany	GSK Investigational Site	Schwedt	Brandenburg
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Korea, Republic of	GSK Investigational Site	Seoul
Latvia	GSK Investigational Site	Riga
Netherlands	GSK Investigational Site	Apeldoorn
Netherlands	GSK Investigational Site	Emmen
Netherlands	GSK Investigational Site	Enschede
Netherlands	GSK Investigational Site	Nijmegen
Netherlands	GSK Investigational Site	Tilburg
Netherlands	GSK Investigational Site	Utrecht
New Zealand	GSK Investigational Site	Christchurch
New Zealand	GSK Investigational Site	Dunedin
New Zealand	GSK Investigational Site	Tauranga
New Zealand	GSK Investigational Site	Whangarei
Poland	GSK Investigational Site	Lodz
Poland	GSK Investigational Site	Lublin
Slovenia	GSK Investigational Site	Celje
Slovenia	GSK Investigational Site	Ljubljana
Slovenia	GSK Investigational Site	Slovenj Gradec
South Africa	GSK Investigational Site	Bloemfontein
South Africa	GSK Investigational Site	Cape Town
South Africa	GSK Investigational Site	Somerset West
Spain	GSK Investigational Site	Barcelona
Spain	GSK Investigational Site	Getafe
Spain	GSK Investigational Site	Granada
Spain	GSK Investigational Site	Marbella
Spain	GSK Investigational Site	San Sebastian
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Valencia
Spain	GSK Investigational Site	Vigo (Pontevedra)
Taiwan	GSK Investigational Site	Hualien
Taiwan	GSK Investigational Site	Taichung
Taiwan	GSK Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment
Secondary	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.