Status:
TERMINATED
Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity
Lead Sponsor:
Janssen-Cilag Ltd.,Thailand
Conditions:
Detrusor Function, Overactive
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effects and tolerability (how well a participant can stand a particular medicine or treatment) of flexible dose Oxybutynin Extended-Release (OXY-ER, Lyrine...
Detailed Description
This is an open-label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time), multi-center study of participants with NDO. The initi...
Eligibility Criteria
Inclusion
- Diagnosis of overactive bladder as a result of neurogenic condition, for example following spinal cord injury, multiple sclerosis (slowly worsening disorder of the central nervous system that causes symptoms such as weakness, incoordination, numbness, problems talking and problems seeing), Parkinson's disease (a progressive disorder of the central nervous system, seen usually in older persons, in which there is slow movement \[due to muscle weakness\], trembling and sweating), or cerebrovascular accidents (CVAs - stroke-sudden loss of blood supply to brain)
- Women must not be pregnant and be of either non-childbearing potential or is using adequate means of birth control
- Overactive bladder symptoms and/or has urge incontinence episodes
- Must have normal results on urine culture tests and on urinalysis
- ECOG (Eastern Cooperative Oncology Group) performance status score of less than or equal to 3
Exclusion
- Participants with 1 or more treatable or conditions, other than neurogenic bladder dysfunction, that may cause urinary incontinence or urgency
- Any medical or unstable condition that precludes their participation in the study or may confound the outcome of the study (participants with or at risk for urinary retention, gastric retention or uncontrolled narrow angle; heart failure or kidney failure; diabetes mellitus; abnormal muscle weakness \[myasthenia gravis\]; paralysis or inactivity in the intestines that prevents material moving through the gut \[intestinal atony or paralytic ileus\]; severe inflammation of the bowel \[ulcerative colitis\] sudden expansion of the large intestine seen in advanced ulcerative colitis or Crohn's disease \[toxic megacolon\]; history of major lower urinary tract surgery \[transurethral resection will be excluded\])
- Hypersensitivity to the investigational drug or any of its ingredients (eg, lactose)
- Pregnant or breast feeding female
- Significant bacteriuria (presence of bacteria in the urine) or pyuria (presence of white blood cells) in the urine
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT01796548
Start Date
December 1 2008
End Date
December 1 2010
Last Update
November 26 2013
Active Locations (3)
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1
Bangkok, Thailand
2
Chiang Mai, Thailand
3
Phathumwan, Thailand