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

January 19, 2017 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 1N1
        • GSK Investigational Site
      • Victoria, British Columbia, Canada, V8T 5G1
        • GSK Investigational Site
      • Victoria, British Columbia, Canada, V8V 3N1
        • GSK Investigational Site
    • New Brunswick
      • Fredericton, New Brunswick, Canada, E3B 5B8
        • GSK Investigational Site
      • Saint John, New Brunswick, Canada, E2L 4L2
        • GSK Investigational Site
    • Nova Scotia
      • Kentville, Nova Scotia, Canada, B4N 4K9
        • GSK Investigational Site
      • Truro, Nova Scotia, Canada, B2N 1L2
        • GSK Investigational Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • GSK Investigational Site
      • Kitchener, Ontario, Canada, N2M 5N4
        • GSK Investigational Site
      • Newmarket, Ontario, Canada, L3X 1W1
        • GSK Investigational Site
      • North Bay, Ontario, Canada, P1B 4Z2
        • GSK Investigational Site
      • Oakville, Ontario, Canada, L6H 3P1
        • GSK Investigational Site
      • Toronto, Ontario, Canada, M6A 3B5
        • GSK Investigational Site
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H3
        • GSK Investigational Site
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • GSK Investigational Site
      • Québec, Quebec, Canada, G1S 2L6
        • GSK Investigational Site
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • GSK Investigational Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • GSK Investigational Site
    • Arizona
      • Peoria, Arizona, United States, 85381 - 4828
        • GSK Investigational Site
      • Phoenix, Arizona, United States, 85023
        • GSK Investigational Site
    • California
      • La Mesa, California, United States, 91942
        • GSK Investigational Site
      • Modesto, California, United States, 95350
        • GSK Investigational Site
      • San Bernardino, California, United States, 92404
        • GSK Investigational Site
      • Torrance, California, United States, 90506
        • GSK Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • GSK Investigational Site
      • Denver, Colorado, United States, 80211
        • GSK Investigational Site
      • Denver, Colorado, United States, 80210
        • GSK Investigational Site
      • Longmont, Colorado, United States, 80501
        • GSK Investigational Site
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • GSK Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • GSK Investigational Site
      • Clearwater, Florida, United States, 33761
        • GSK Investigational Site
      • Fort Myers, Florida, United States, 33916
        • GSK Investigational Site
      • Miami, Florida, United States, 33143
        • GSK Investigational Site
      • Miami, Florida, United States, 33156
        • GSK Investigational Site
      • Ocala, Florida, United States, 34474
        • GSK Investigational Site
      • Pembroke Pines, Florida, United States, 33024
        • GSK Investigational Site
      • Sarasota, Florida, United States, 34237
        • GSK Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • GSK Investigational Site
    • Illinois
      • Melrose Park, Illinois, United States, 60160
        • GSK Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46254
        • GSK Investigational Site
      • Jeffersonville, Indiana, United States, 47130
        • GSK Investigational Site
      • Newburgh, Indiana, United States, 47630
        • GSK Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • GSK Investigational Site
    • New York
      • Albany, New York, United States, 12205
        • GSK Investigational Site
      • Kingston, New York, United States, 12401
        • GSK Investigational Site
      • Poughkeepsie, New York, United States, 12601
        • GSK Investigational Site
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • GSK Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • GSK Investigational Site
    • Oregon
      • Springfield, Oregon, United States, 97477
        • GSK Investigational Site
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • GSK Investigational Site
      • Lancaster, Pennsylvania, United States, 17604
        • GSK Investigational Site
      • Sellersville, Pennsylvania, United States, 18960
        • GSK Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • GSK Investigational Site
    • South Carolina
      • Simpsonville, South Carolina, United States, 29681
        • GSK Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • GSK Investigational Site
    • Texas
      • Dallas, Texas, United States, 75234
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23294
        • GSK Investigational Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (ACTUAL)

February 1, 2007

Study Completion (ACTUAL)

February 1, 2007

Study Registration Dates

First Submitted

May 1, 2006

First Submitted That Met QC Criteria

May 1, 2006

First Posted (ESTIMATE)

May 3, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NKB105022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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