NCT01796548|TerminatedPhase 4ResultsDMC
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Slow rate of participant's enrollment
RONDO
Extended-Release Oxybutynin in the Treatment of Neurogenic Detrusor Overactivity (RONDO)
Sponsor study identifier
Secondary identifiers
interventional
17
1 country
3
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2010
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
December 2010
Actual (reported)December 2010
Actual (reported)January 30, 2013
Actual (reported)February 21, 2013
Actual (reported)July 31, 2013
Actual (reported)Maximal Detrusor Pressure
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.
Week 12
Maximal Cystometric Capacity (MCC)
Baseline and Week 12
Detrusor Leakpoint Pressure
Baseline and Week 12
Post-Void Residual Urine Volume
Baseline and Week 12
Reflex Volume
Baseline and Week 12
Urge Incontinence Episodes
Baseline, Week 4 and Week 12
Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Bangkok, Thailand
Chiang Mai, Thailand
Phathumwan, Thailand
Janssen-Cilag Ltd.,Thailand Clinical trial
Janssen-Cilag Ltd.,Thailand
17 participants (actual enrollment reported by the registry).
First Submitted
January 30, 2013
First Posted
February 21, 2013
Study Start
December 2008
Date type not reportedThis date has not been verified as actual or estimated.
Study of Darifenacin in Patients Suffering From Multiple Sclerosis and Neurogenic Detrusor Overactivity
Contact the study team to confirm eligibility.
Primary Completion
December 2010
Actual (reported)Study Completion
December 2010
Actual (reported)Last Updated
November 26, 2013
Results First Posted
July 31, 2013
Record last verified: 2013-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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