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

Primary Purpose

Incontinence, Urinary and Urinary Bladder, Overactive, Overactive Bladder

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW679769 oral tablets
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incontinence, Urinary and Urinary Bladder, Overactive focused on measuring Overactive Bladder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Outcomes

Primary Outcome Measures

Percent change from baseline to Week 12 in the number of incontinence episodes/24 hrs

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

Full Information

First Posted
May 1, 2006
Last Updated
January 19, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00321477
Brief Title
A Study Of GW679769 Compared To Placebo In Women With Overactive Bladder
Official Title
NK1 Receptor Antagonist vs Placebo in the Treatment of Overactive Bladder Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incontinence, Urinary and Urinary Bladder, Overactive, Overactive Bladder
Keywords
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
GW679769 oral tablets
Primary Outcome Measure Information:
Title
Percent change from baseline to Week 12 in the number of incontinence episodes/24 hrs
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
GSK Investigational Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381 - 4828
Country
United States
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
GSK Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
GSK Investigational Site
City
Modesto
State/Province
California
ZIP/Postal Code
95350
Country
United States
Facility Name
GSK Investigational Site
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
GSK Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90506
Country
United States
Facility Name
GSK Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
GSK Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
GSK Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
GSK Investigational Site
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
GSK Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
GSK Investigational Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
GSK Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
GSK Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
GSK Investigational Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
GSK Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
GSK Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
GSK Investigational Site
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
Facility Name
GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
Facility Name
GSK Investigational Site
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
GSK Investigational Site
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
GSK Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
GSK Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
GSK Investigational Site
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
GSK Investigational Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
GSK Investigational Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
GSK Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
GSK Investigational Site
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
GSK Investigational Site
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
GSK Investigational Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
GSK Investigational Site
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
GSK Investigational Site
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
GSK Investigational Site
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29681
Country
United States
Facility Name
GSK Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
GSK Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
GSK Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
GSK Investigational Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1N1
Country
Canada
Facility Name
GSK Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
Facility Name
GSK Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8V 3N1
Country
Canada
Facility Name
GSK Investigational Site
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 5B8
Country
Canada
Facility Name
GSK Investigational Site
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
GSK Investigational Site
City
Kentville
State/Province
Nova Scotia
ZIP/Postal Code
B4N 4K9
Country
Canada
Facility Name
GSK Investigational Site
City
Truro
State/Province
Nova Scotia
ZIP/Postal Code
B2N 1L2
Country
Canada
Facility Name
GSK Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
GSK Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N4
Country
Canada
Facility Name
GSK Investigational Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3X 1W1
Country
Canada
Facility Name
GSK Investigational Site
City
North Bay
State/Province
Ontario
ZIP/Postal Code
P1B 4Z2
Country
Canada
Facility Name
GSK Investigational Site
City
Oakville
State/Province
Ontario
ZIP/Postal Code
L6H 3P1
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
Facility Name
GSK Investigational Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H3
Country
Canada
Facility Name
GSK Investigational Site
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
GSK Investigational Site
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1S 2L6
Country
Canada
Facility Name
GSK Investigational Site
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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