Effects Of GW679769 On Bladder Nerve Function And Symptoms Of Overactive Bladder In Spinal Cord Injury Patients
Stopped early · Phase 2
Conditions studied: Incontinence, Urinary and Urinary Bladder, Overactive, Overactive Bladder
In brief
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.
Key facts
- Study ID
- NCT00332319
- Run by
- GlaxoSmithKline
- People needed
- 1
- Starts
- 2006-01-01
- Expected to finish
- 2007-02-01
- Last updated by the study team
- 2015-04-17
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- GSK Investigational Site — Long Beach, California, United States
- GSK Investigational Site — Cleveland, Ohio, United States
- GSK Investigational Site — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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