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Effects Of GW679769 On Bladder Nerve Function And Symptoms Of Overactive Bladder In Spinal Cord Injury Patients

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00332319
First received: May 30, 2006
Last updated: May 31, 2012
Last verified: March 2011
History of Changes
  Purpose

This is a two-part study in which Part A will assess the effects of GW679769 after 1 dose on the function of the nerves that supply the bladder. The technique for measuring the nerves function is called Neurometry. Part B will assess the effect of repeat doses of GW679769 on the bladder nerve function. Part B will also assess the effects of the drug on overactive bladder symptoms using a three-day patient diary.


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

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change in bladder nerve activity assessed by neurometry before and after a single dose of GW679769 and placebo (part A) and after 28 days of drug or placebo treatment (part B).

Secondary Outcome Measures:
  • Improvement of OAB symptoms (incontinence, frequency of urination, reduction in urgency, decrease in night-time urination episodes).

Estimated Enrollment: 40
Study Start Date: January 2006
Intervention Details:
    Drug: GW679769
    Other Name: GW679769
Detailed Description:

A randomized, double-blind, placebo-controlled study to evaluate the effects of GW679769 on Current Perception Threshold (CPT) following a single 150 mg dose (Part A) and to evaluate the effect of CPT and symptoms of overactive bladder following 28 days of repeat dosing with 120 mg GW679769 administered once daily (Part B) in patients with neurogenic bladder due to incomplete spinal cord injury

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Spinal cord injury patients with overactive bladder symptoms including urge incontinence, urgency, frequency and night-time urination but without bladder related pain.
  • The injury must be above S1-3

Exclusion criteria:

  • Spinal cord injury suffered within 6 months.
  • History of interstitial cystitis, radiation cystitis, pelvic irradiation, or myocardial infarction with 1 year prior to screening.
  • Pregnant or nursing females.
  • Patients who have had hypersensitivity to lidocaine.
  • Patients who are taking oral corticosteroids.
  • Patients with active peptic ulcer disease (PUD) and/or history of PUD of an unknown etiology.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332319

Locations
United States, California
GSK Investigational Site
Long Beach, California, United States, 90806
United States, Ohio
GSK Investigational Site
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00332319     History of Changes
Other Study ID Numbers: NKB104846
Study First Received: May 30, 2006
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
spinal cord injury
urgency
Overactive bladder
neurogenic
 neurometry
frequency
urge incontinence

Additional relevant MeSH terms:
Spinal Cord Injuries
Urinary Incontinence
Urinary Bladder, Overactive
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
 Wounds and Injuries
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on May 16, 2013