Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity
Information source: Janssen-Cilag Ltd.,Thailand
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Detrusor Function, Overactive
Intervention: Oxybutinin Extended-Release (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Janssen-Cilag Ltd.,Thailand Official(s) and/or principal investigator(s): Janssen-Cilag Ltd.,Thailand Clinical trial, Study Director, Affiliation: Janssen-Cilag Ltd.,Thailand
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, Lyrinel) including safety and quality of life assessment in
participants with neurogenic detrusor overactivity (NDO - the nerves mediating the detrusor
muscle do not work properly leading to frequent feeling of need to urinate during the day,
night, or both).
Clinical Details
Official title: Extended-Release Oxybutynin in the Treatment of Neurogenic Detrusor Overactivity (RONDO)
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Maximal Detrusor Pressure
Secondary outcome: Maximal Cystometric Capacity (MCC)Detrusor Leakpoint Pressure Post-Void Residual Urine Volume Reflex Volume Urge Incontinence Episodes Total Incontinence Episodes Percentage of Participants With no Episodes of Urge-Urinary Incontinence King Health Questionnaire Score
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 initial dose of Oxybutynin ER will be 10 milligram (mg) and will
be titrated to a maximum of 30 mg. Dosage will be adjusted in 5-mg increments at
approximately 14-day intervals until continence is achieved or the participant cannot
tolerate side effects. The duration of participation in the study will be 12 weeks. The
study will consist of 6 visits: baseline, Weeks 2, 4, 6, 8 and 12. Week 4 and Week 8 will be
telephone visits. Overall safety and efficacy of Oxybutinin ER will be assessed as well as
safety and efficacy during the titration and maintenance phases. The efficacy of treatment
will be assessed using urodynamic parameters (the force and flow of urine) and clinical
parameters (voiding diary and catheterization [use or insertion of a tubular device to drain
the bladder] schedules). The quality of life will also be monitored in the study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Bangkok, Thailand
Chiangmai, Thailand
Phathumwan, Thailand
Additional Information
Starting date: December 2008
Last updated: October 31, 2013
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