Status:
TERMINATED
Effects Of GW679769 On Bladder Nerve Function And Symptoms Of Overactive Bladder In Spinal Cord Injury Patients
Lead Sponsor:
GlaxoSmithKline
Conditions:
Incontinence, Urinary and Urinary Bladder, Overactive
Overactive Bladder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 call...
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2007
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00332319
Start Date
January 1 2006
End Date
February 1 2007
Last Update
April 17 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
GSK Investigational Site
Long Beach, California, United States, 90806
2
GSK Investigational Site
Cleveland, Ohio, United States, 44195
3
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107