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

NCT00321477 | Completed Phase 2

• 1 other identifier: NKB105022
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 58

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.

Conditions

Incontinence, Urinary and Urinary Bladder, Overactive; Overactive Bladder

Keywords

Overactive Bladder

Outcome Measures

Primary Outcomes (1)

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

  12 weeks

Secondary Outcomes (1)

• 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

Interventions

GW679769 oral tablets DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (58)

GSK Investigational Site

Huntsville, Alabama, 35801, United States

Location

GSK Investigational Site

Peoria, Arizona, 85381 - 4828, United States

Location

GSK Investigational Site

Phoenix, Arizona, 85023, United States

Location

GSK Investigational Site

La Mesa, California, 91942, United States

Location

GSK Investigational Site

Modesto, California, 95350, United States

Location

GSK Investigational Site

San Bernardino, California, 92404, United States

Location

GSK Investigational Site

Torrance, California, 90506, United States

Location

GSK Investigational Site

Aurora, Colorado, 80012, United States

Location

GSK Investigational Site

Denver, Colorado, 80210, United States

Location

GSK Investigational Site

Denver, Colorado, 80211, United States

Location

GSK Investigational Site

Longmont, Colorado, 80501, United States

Location

GSK Investigational Site

Waterbury, Connecticut, 06708, United States

Location

GSK Investigational Site

Aventura, Florida, 33180, United States

Location

GSK Investigational Site

Clearwater, Florida, 33761, United States

Location

GSK Investigational Site

Fort Myers, Florida, 33916, United States

Location

GSK Investigational Site

Miami, Florida, 33143, United States

Location

GSK Investigational Site

Miami, Florida, 33156, United States

Location

GSK Investigational Site

Ocala, Florida, 34474, United States

Location

GSK Investigational Site

Pembroke Pines, Florida, 33024, United States

Location

GSK Investigational Site

Sarasota, Florida, 34237, United States

Location

GSK Investigational Site

Atlanta, Georgia, 30309, United States

Location

GSK Investigational Site

Melrose Park, Illinois, 60160, United States

Location

GSK Investigational Site

Indianapolis, Indiana, 46254, United States

Location

GSK Investigational Site

Jeffersonville, Indiana, 47130, United States

Location

GSK Investigational Site

Newburgh, Indiana, 47630, United States

Location

GSK Investigational Site

Lexington, Kentucky, 40509, United States

Location

GSK Investigational Site

Albany, New York, 12205, United States

Location

GSK Investigational Site

Kingston, New York, 12401, United States

Location

GSK Investigational Site

Poughkeepsie, New York, 12601, United States

Location

GSK Investigational Site

Salisbury, North Carolina, 28144, United States

Location

GSK Investigational Site

Winston-Salem, North Carolina, 27103, United States

Location

GSK Investigational Site

Springfield, Oregon, 97477, United States

Location

GSK Investigational Site

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

GSK Investigational Site

Lancaster, Pennsylvania, 17604, United States

Location

GSK Investigational Site

Sellersville, Pennsylvania, 18960, United States

Location

GSK Investigational Site

Providence, Rhode Island, 02906, United States

Location

GSK Investigational Site

Simpsonville, South Carolina, 29681, United States

Location

GSK Investigational Site

Nashville, Tennessee, 37232, United States

Location

GSK Investigational Site

Dallas, Texas, 75234, United States

Location

GSK Investigational Site

Richmond, Virginia, 23294, United States

Location

GSK Investigational Site

Tacoma, Washington, 98405, United States

Location

GSK Investigational Site

Surrey, British Columbia, V3V 1N1, Canada

Location

GSK Investigational Site

Victoria, British Columbia, V8T 5G1, Canada

Location

GSK Investigational Site

Victoria, British Columbia, V8V 3N1, Canada

Location

GSK Investigational Site

Fredericton, New Brunswick, E3B 5B8, Canada

Location

GSK Investigational Site

Saint John, New Brunswick, E2L 4L2, Canada

Location

GSK Investigational Site

Kentville, Nova Scotia, B4N 4K9, Canada

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

GSK Investigational Site

Barrie, Ontario, L4M 7G1, Canada

Location

GSK Investigational Site

Kitchener, Ontario, N2M 5N4, Canada

Location

GSK Investigational Site

Newmarket, Ontario, L3X 1W1, Canada

Location

GSK Investigational Site

North Bay, Ontario, P1B 4Z2, Canada

Location

GSK Investigational Site

Oakville, Ontario, L6H 3P1, Canada

Location

GSK Investigational Site

Toronto, Ontario, M6A 3B5, Canada

Location

GSK Investigational Site

Greenfield Park, Quebec, J4V 2H3, Canada

Location

GSK Investigational Site

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

GSK Investigational Site

Québec, Quebec, G1S 2L6, Canada

Location

GSK Investigational Site

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

casopitant

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2006
• First Posted: May 3, 2006
• Study Start: December 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2007
• Last Updated: January 20, 2017

Record last verified: 2017-01

Locations

CA (17); US (41)