Status:
COMPLETED
Dose Ranging Study Of Solabegron Versus Placebo In Female Patients With Overactive Bladder Symptoms
Lead Sponsor:
GlaxoSmithKline
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18-80 years
Phase:
PHASE2
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
- 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
- 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.
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00343486
Start Date
May 1 2006
Last Update
May 18 2009
Active Locations (66)
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1
GSK Investigational Site
Av Córdoba 2424, Buenos Aires, Argentina, 1120
2
GSK Investigational Site
Bahía Blanca, Buenos Aires, Argentina, 8001
3
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1406CPC
4
GSK Investigational Site
Ciudad de Buenos Aires, Buenos Aires, Argentina, C1425BGV