Back to resultsEffects Of GW679769 On Bladder Nerve Function And Symptoms Of Overactive Bladder In Spinal Cord Injury Patients
Primary Purpose
Incontinence, Urinary and Urinary Bladder, Overactive, Overactive Bladder
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GW679769
Sponsored by
About this trial
This is an interventional treatment trial for Incontinence, Urinary and Urinary Bladder, Overactive focused on measuring spinal cord injury, urgency, Overactive bladder, neurogenic, neurometry, frequency, urge incontinence
Eligibility 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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Outcomes
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00332319
Brief Title
Effects Of GW679769 On Bladder Nerve Function And Symptoms Of Overactive Bladder In Spinal Cord Injury Patients
Official Title
See Detailed Description
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Study Start Date
January 2006 (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 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.
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
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
spinal cord injury, urgency, Overactive bladder, neurogenic, neurometry, frequency, urge incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW679769
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Improvement of OAB symptoms (incontinence, frequency of urination, reduction in urgency, decrease in night-time urination episodes).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
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
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
GSK Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects Of GW679769 On Bladder Nerve Function And Symptoms Of Overactive Bladder In Spinal Cord Injury Patients
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