Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00321477
First received: May 1, 2006
Last updated: May 31, 2012
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Incontinence, Urinary and Urinary Bladder, Overactive
Overactive Bladder
Drug: GW679769 oral tablets
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: See Detailed Description

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Percent change from baseline to Week 12 in the number of incontinence episodes/24 hrs [ Time Frame: 12 weeks ]

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 [ Time Frame: 12 Weeks ]

Estimated Enrollment: 160
Study Start Date: December 2005
Study Completion Date: February 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: GW679769 oral tablets
    Other Name: GW679769 oral tablets
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00321477

  Show 58 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00321477     History of Changes
Other Study ID Numbers: NKB105022
Study First Received: May 1, 2006
Last Updated: May 31, 2012
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Overactive Bladder

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Incontinence
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urination Disorders
Urologic Diseases
Urological Manifestations
Casopitant
Antiemetics
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014