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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-02-28

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Incontinence, Urinary and Urinary Bladder, Overactive Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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GW679769

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No