Incontinence, Urinary and Urinary Bladder, Overactive, Overactive Bladder
Conditions
Keywords
Overactive Bladder
Brief summary
This is a Phase IIa study to evaluate the efficacy, safety and tolerability of GW679769 vs placebo on symptoms of urgency with urge incontinence, frequency and nocturia associated with overactive bladder in women.
Detailed description
A Twelve-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Forced Titration, Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as well as the Pharmacokinetic Profile of 60 mg and 120 mg of GW679769 administered once daily vs Placebo in Women with Overactive Bladder
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Female subjects with overactive bladder with symptoms of urgency with urge incontinence and frequency which may be associated with nocturia but without bladder pain. * Must not be pregnant. * Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol. * Body weight in the range of = 45 kg and \<100 kg.
Exclusion criteria
* Stage III/IV pelvic organ prolapse with or without cystocele. * History of interstitial cystitis or bladder related pain. * Subjects with 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. * Subjects with 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. * 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. * Participated in any clinical trial of an investigation drug that may affect urinary function within 3 months of enrollment into the study. * Received any investigational product within 30 days of enrollment into the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline to Week 12 in the number of incontinence episodes/24 hrs | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to Weeks 6 and 12 in the following endpoints: Number of micturitions/24 hrs Number of urgency episodes/24 hrs Number of nocturia episodes/24 hrs | 12 Weeks |
Countries
Canada, United States
Outcome results
None listed