Effects Of GW679769 On Bladder Nerve Function And Symptoms Of Overactive Bladder In Spinal Cord Injury Patients
| Status: | Terminated |
|---|---|
| Conditions: | Overactive Bladder, Hospital, Urology |
| Therapuetic Areas: | Gastroenterology, Nephrology / Urology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/14/2017 |
| Start Date: | January 2006 |
| End Date: | February 2007 |
See Detailed Description
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.
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.
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
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
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.
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