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

Overactive Bladder Clinical Trial

Official title:

See Detailed Description

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00332319
• Other study ID #: NKB104846
• Status: Terminated
• Phase: Phase 2
• First received: May 30, 2006
• Last updated: April 15, 2015
• Start date: January 2006
• Est. completion date: February 2007

Study information

• Verified date: March 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: February 2007
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Enuresis
• Incontinence, Urinary and Urinary Bladder, Overactive
• Overactive Bladder
• Spinal Cord Injuries
• Urinary Bladder, Overactive
• Urinary Incontinence

Intervention

Drug:
• GW679769

Locations

Country	Name	City	State
United States	GSK Investigational Site	Cleveland	Ohio
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Improvement of OAB symptoms (incontinence, frequency of urination, reduction in urgency, decrease in night-time urination episodes).