A Study Of GW679769 Compared To Placebo In Women With Overactive Bladder - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00321477

Purpose

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.

Condition	Intervention	Phase
Overactive Bladder	Drug: GW679769 oral tablets	Phase II

Drug Information available for: GW679769

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Official Title:	See Detailed Description

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Percent change from baseline to Week 12 in the number of incontinence episodes/24 hrs [ Time Frame: 12 weeks ]

Secondary Outcome Measures:

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 [ Time Frame: 12 Weeks ]

Estimated Enrollment:	160
Study Start Date:	December 2005
Study Completion Date:	February 2007
Primary Completion Date:	February 2007 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321477

Show 58 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	NKB105022
Study First Received:	May 1, 2006
Last Updated:	October 13, 2008
ClinicalTrials.gov Identifier:	NCT00321477
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Overactive Bladder

Study placed in the following topic categories:

Signs and Symptoms
Urinary Bladder, Overactive
Cystocele
Urologic Diseases
Urinary Bladder Diseases

Additional relevant MeSH terms:

Urological Manifestations

ClinicalTrials.gov processed this record on January 16, 2009