A Study Of GW679769 Compared To Placebo In Women With Overactive Bladder

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 2

Conditions

Incontinence, Urinary and Urinary Bladder, Overactive

Overactive Bladder

Treatments

Drug: GW679769 oral tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT00321477

NKB105022

Details and patient eligibility

About

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.

Full 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

Enrollment

160 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.