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

NCT ID: NCT00321477

Last Updated: 2017-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-02-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Incontinence, Urinary and Urinary Bladder, Overactive Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW679769 oral tablets

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Huntsville, Alabama, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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La Mesa, California, United States

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Modesto, California, United States

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San Bernardino, California, United States

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Torrance, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Longmont, Colorado, United States

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Waterbury, Connecticut, United States

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Aventura, Florida, United States

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Clearwater, Florida, United States

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Fort Myers, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Ocala, Florida, United States

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Pembroke Pines, Florida, United States

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Sarasota, Florida, United States

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Atlanta, Georgia, United States

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Melrose Park, Illinois, United States

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Indianapolis, Indiana, United States

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Jeffersonville, Indiana, United States

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Newburgh, Indiana, United States

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Lexington, Kentucky, United States

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Albany, New York, United States

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Kingston, New York, United States

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Poughkeepsie, New York, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Springfield, Oregon, United States

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Bala-Cynwyd, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Providence, Rhode Island, United States

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Simpsonville, South Carolina, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Surrey, British Columbia, Canada

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Victoria, British Columbia, Canada

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Victoria, British Columbia, Canada

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Fredericton, New Brunswick, Canada

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Saint John, New Brunswick, Canada

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Kentville, Nova Scotia, Canada

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Truro, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Kitchener, Ontario, Canada

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Newmarket, Ontario, Canada

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North Bay, Ontario, Canada

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Oakville, Ontario, Canada

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Toronto, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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GSK Investigational Site

Québec, Quebec, Canada

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GSK Investigational Site

Sherbrooke, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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NKB105022

Identifier Type: -

Identifier Source: org_study_id

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