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NCT00321477 Clinical Trial

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

Overactive Bladder Clinical Trial

Official title:
NK1 Receptor Antagonist vs Placebo in the Treatment of Overactive Bladder Symptoms

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00321477
Other study ID # NKB105022
Secondary ID
Status Completed
Phase Phase 2
First received May 1, 2006
Last updated January 19, 2017
Start date December 2005
Est. completion date February 2007

Study information
Verified date January 2017
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Completed
Enrollment 160
Est. completion date February 2007
Est. primary completion date February 2007
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 75 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GW679769 oral tablets

Locations
Country Name City State
Canada GSK Investigational Site Barrie Ontario
Canada GSK Investigational Site Fredericton New Brunswick
Canada GSK Investigational Site Greenfield Park Quebec
Canada GSK Investigational Site Kentville Nova Scotia
Canada GSK Investigational Site Kitchener Ontario
Canada GSK Investigational Site Newmarket Ontario
Canada GSK Investigational Site North Bay Ontario
Canada GSK Investigational Site Oakville Ontario
Canada GSK Investigational Site Pointe-Claire Quebec
Canada GSK Investigational Site Québec Quebec
Canada GSK Investigational Site Saint John New Brunswick
Canada GSK Investigational Site Sherbrooke Quebec
Canada GSK Investigational Site Surrey British Columbia
Canada GSK Investigational Site Toronto Ontario
Canada GSK Investigational Site Truro Nova Scotia
Canada GSK Investigational Site Victoria British Columbia
Canada GSK Investigational Site Victoria British Columbia
United States GSK Investigational Site Albany New York
United States GSK Investigational Site Atlanta Georgia
United States GSK Investigational Site Aurora Colorado
United States GSK Investigational Site Aventura Florida
United States GSK Investigational Site Bala Cynwyd Pennsylvania
United States GSK Investigational Site Clearwater Florida
United States GSK Investigational Site Dallas Texas
United States GSK Investigational Site Denver Colorado
United States GSK Investigational Site Denver Colorado
United States GSK Investigational Site Fort Myers Florida
United States GSK Investigational Site Huntsville Alabama
United States GSK Investigational Site Indianapolis Indiana
United States GSK Investigational Site Jeffersonville Indiana
United States GSK Investigational Site Kingston New York
United States GSK Investigational Site La Mesa California
United States GSK Investigational Site Lancaster Pennsylvania
United States GSK Investigational Site Lexington Kentucky
United States GSK Investigational Site Longmont Colorado
United States GSK Investigational Site Melrose Park Illinois
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Miami Florida
United States GSK Investigational Site Modesto California
United States GSK Investigational Site Nashville Tennessee
United States GSK Investigational Site Newburgh Indiana
United States GSK Investigational Site Ocala Florida
United States GSK Investigational Site Pembroke Pines Florida
United States GSK Investigational Site Peoria Arizona
United States GSK Investigational Site Phoenix Arizona
United States GSK Investigational Site Poughkeepsie New York
United States GSK Investigational Site Providence Rhode Island
United States GSK Investigational Site Richmond Virginia
United States GSK Investigational Site Salisbury North Carolina
United States GSK Investigational Site San Bernardino California
United States GSK Investigational Site Sarasota Florida
United States GSK Investigational Site Sellersville Pennsylvania
United States GSK Investigational Site Simpsonville South Carolina
United States GSK Investigational Site Springfield Oregon
United States GSK Investigational Site Tacoma Washington
United States GSK Investigational Site Torrance California
United States GSK Investigational Site Waterbury Connecticut
United States GSK Investigational Site Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change from baseline to Week 12 in the number of incontinence episodes/24 hrs 12 weeks
Secondary 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
See also
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