- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01796548
Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity (RONDO)
October 31, 2013 updated by: Janssen-Cilag Ltd.,Thailand
Extended-Release Oxybutynin in the Treatment of Neurogenic Detrusor Overactivity (RONDO)
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bangkok, Thailand
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Chiangmai, Thailand
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Phathumwan, Thailand
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Oxybutynin Extended-Release
Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
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Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal Detrusor Pressure
Time Frame: Week 12
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Maximal detrusor pressure represents the maximum pressure (peak amplitude) in the bladder during the first involuntary contraction of the bladder muscle.
Detrusor pressure is the component of intravesical (in the bladder) pressure that is created by forces in the bladder wall (passive and active).
It was estimated by subtracting abdominal pressure from intravesical pressure.
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Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximal Cystometric Capacity (MCC)
Time Frame: Baseline and Week 12
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MCC represents the maximum volume of urine the bladder holds.
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Baseline and Week 12
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Detrusor Leakpoint Pressure
Time Frame: Baseline and Week 12
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Detrusor leakpoint pressure is the level of pressure at which leakage of urine through the urethra occurs as the bladder fills without an increase in abdominal pressure.
This was a measure of both strength of the urethral sphincters and compliance of the detrusor muscle.
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Baseline and Week 12
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Post-Void Residual Urine Volume
Time Frame: Baseline and Week 12
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Post-void residual urine volume is the amount of urine remaining in the bladder after void completion.
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Baseline and Week 12
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Reflex Volume
Time Frame: Baseline and Week 12
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Reflex volume is the infused volume that induces the first detrusor contraction.
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Baseline and Week 12
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Urge Incontinence Episodes
Time Frame: Baseline, Week 4 and Week 12
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Urge incontinence episodes were reported.
Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency with sudden feeling to go to toilet.
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Baseline, Week 4 and Week 12
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Total Incontinence Episodes
Time Frame: Baseline, Week 4 and Week 12
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Episodes of total urinary incontinence were reported.
Urinary incontinence is the complaint of any involuntary leakage of urine.
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Baseline, Week 4 and Week 12
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Percentage of Participants With no Episodes of Urge-Urinary Incontinence
Time Frame: Baseline, Week 4 and Week 12
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Percentage of participants with no episodes of urge urinary incontinence was reported.
Urge urinary incontinence is the complaint of involuntary leakage accompanied by or immediately preceded by urgency.
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Baseline, Week 4 and Week 12
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King Health Questionnaire Score
Time Frame: Baseline and Week 12
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King Health Questionnaire assesses the physical and psycho-social aspects of the disease state.
It is a self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep or energy, and severity of urinary symptoms).
All domains were assessed in a range: 0-100, where 0=best outcome/response and 100=worst outcome or response.
Lower scores indicates better outcome or response.
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Baseline and Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (ACTUAL)
December 1, 2010
Study Completion (ACTUAL)
December 1, 2010
Study Registration Dates
First Submitted
January 30, 2013
First Submitted That Met QC Criteria
February 19, 2013
First Posted (ESTIMATE)
February 21, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
November 26, 2013
Last Update Submitted That Met QC Criteria
October 31, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR015205
- R016446OAB4011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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