Detrusor Function, OveractivePhase 4RONDONCT01796548
Extended-Release Oxybutynin for the Treatment of Neurogenic Detrusor Overactivity
A Phase 4 study testing Oxybutinin Extended-Release in people with Detrusor Function, Overactive, run by Janssen-Cilag Ltd.,Thailand at 3 sites in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Detrusor Function, Overactive
- What is being tested?
- Oxybutinin Extended-Release
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 3 sitesThailand
- Study dates
- Dec 2008to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Detrusor Function, Overactive
- Being tested
- Oxybutinin Extended-Release
- Keywords
- Detrusor function, overactive, Urinary incontinence, Oxybutynin, Lyrinel
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybutinin Extended-ReleaseDrug
Also called Lyrinel
Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
| Study group | Role | What they receive |
|---|---|---|
| Oxybutynin Extended-Release | Experimental | Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally Receives: Drug: Oxybutinin Extended-Release |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (8)
Maximal Cystometric Capacity (MCC)
MCC represents the maximum volume of urine the bladder holds.
Measured: Baseline and Week 12
Detrusor Leakpoint Pressure
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.
Measured: Baseline and Week 12
Post-Void Residual Urine Volume
Post-void residual urine volume is the amount of urine remaining in the bladder after void completion.
Measured: Baseline and Week 12
Reflex Volume
Reflex volume is the infused volume that induces the first detrusor contraction.
Measured: Baseline and Week 12
Urge Incontinence Episodes
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.
Measured: Baseline, Week 4 and Week 12
Total Incontinence Episodes
Episodes of total urinary incontinence were reported. Urinary incontinence is the complaint of any involuntary leakage of urine.
Measured: Baseline, Week 4 and Week 12
Percentage of Participants With no Episodes of Urge-Urinary Incontinence
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.
Measured: Baseline, Week 4 and Week 12
King Health Questionnaire Score
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startDec 2008
- Primary completionDec 2010
- Study completionDec 2010
Why it stopped: Slow rate of participant's enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Detrusor Function, OveractiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.,Thailand
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd.,Thailand Clinical trial, Study director, Janssen-Cilag Ltd.,Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01796548
- Sponsor's protocol ID
- CR015205
- Other IDs
- R016446OAB4011
- Acronym
- RONDO
- Status last verified
- Oct 2013
- First submitted
- 30 Jan 2013
- Last updated
- 26 Nov 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended-Release Oxybutynin in the Treatment of Neurogenic Detrusor Overactivity (RONDO)
- ClinicalTrials.gov ID
- NCT01796548
- Acronym / sponsor ID
- RONDO / CR015205
- Conditions
- Detrusor Function, Overactive
- Keywords
- Detrusor function, overactive, Urinary incontinence, Oxybutynin, Lyrinel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow rate of participant's enrollment
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.,ThailandIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Feb 2013 (estimated)
- Results
- Posted 31 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxybutynin Extended-Release | Experimental | Drug: Oxybutinin Extended-ReleaseOxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxybutinin Extended-ReleaseAlso: LyrinelOxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally | Drug | Oxybutynin Extended-Release |
Primary outcome
Maximal Detrusor Pressure
Time frame: Week 12
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.
8 secondary outcomes
Maximal Cystometric Capacity (MCC)
Time frame: Baseline and Week 12
Detrusor Leakpoint Pressure
Time frame: Baseline and Week 12
Post-Void Residual Urine Volume
Time frame: Baseline and Week 12
Reflex Volume
Time frame: Baseline and Week 12
Urge Incontinence Episodes
Time frame: Baseline, Week 4 and Week 12
Total Incontinence Episodes
Time frame: Baseline, Week 4 and Week 12
Percentage of Participants With no Episodes of Urge-Urinary Incontinence
Time frame: Baseline, Week 4 and Week 12
King Health Questionnaire Score
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Ltd.,Thailand Clinical trial study director
Janssen-Cilag Ltd.,Thailand
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxybutinin Extended-Release in people with Detrusor Function, Overactive, run by Janssen-Cilag Ltd.,Thailand at 3 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Detrusor Pressure (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2013.