Overactive Bladder
Conditions
Keywords
Overactive Bladder
Brief summary
This study will test the effectiveness and safety of two doses of solabegron against placebo in reducing the symptoms of overactive bladder.
Interventions
DRUGSolabegron
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent reduction in the number of incontinence episodes per 24 hrs after 8 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Argentina, Australia, Finland, France, Germany, Latvia, Netherlands, New Zealand, Poland, Slovenia, South Africa, South Korea, Spain, Taiwan
Outcome results
None listed