Status:
COMPLETED
A Study Of GW679769 Compared To Placebo In Women With Overactive Bladder
Lead Sponsor:
GlaxoSmithKline
Conditions:
Incontinence, Urinary and Urinary Bladder, Overactive
Overactive Bladder
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
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 blad...
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 Prof...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2007
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00321477
Start Date
December 1 2005
End Date
February 1 2007
Last Update
January 20 2017
Active Locations (58)
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1
GSK Investigational Site
Huntsville, Alabama, United States, 35801
2
GSK Investigational Site
Peoria, Arizona, United States, 85381 - 4828
3
GSK Investigational Site
Phoenix, Arizona, United States, 85023
4
GSK Investigational Site
La Mesa, California, United States, 91942