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

GlaxoSmithKline (GSK)

Status and phase

Terminated

Phase 2

Conditions

Incontinence, Urinary and Urinary Bladder, Overactive

Overactive Bladder

Treatments

Drug: GW679769

Study type

Interventional

Funder types

Industry

Identifiers

NCT00332319

NKB104846

Details and patient eligibility

About

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.

Full 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

Enrollment

1 patient

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.