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| ID | Type | Description | Link |
|---|---|---|---|
| R016446OAB4011 |
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Slow rate of participant's enrollment
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxybutynin Extended-Release | Experimental | Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutinin Extended-Release | Drug | Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Cystometric Capacity (MCC) | MCC represents the maximum volume of urine the bladder holds. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd.,Thailand Clinical trial | Janssen-Cilag Ltd.,Thailand | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangkok | Thailand | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxybutynin | Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxybutynin | Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment. 'Number of participants analyzed for the baseline characteristic was intent-to-treat (ITT) population which included all randomly assigned participants who received at least 1 dose of study medication and fulfilled all eligibility criteria.' |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Intent-to treat (ITT) population included all randomly assigned participants who received at least 1 dose of study medication and fulfilled all eligibility criteria. | Posted | Mean | Standard Deviation | Centimeter of water | Week 12 |
|
Baseline up to Week 12
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oxybutynin | Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pollakiuria | Renal and urinary disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Medical Affairs, Janssen-Cilag (Thailand) | 662-792-7200 | 5888 |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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. | Baseline and Week 12 |
| Reflex Volume | Reflex volume is the infused volume that induces the first detrusor contraction. | 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. | 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. | 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. | 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. | Baseline and Week 12 |
| Chiang Mai |
| Thailand |
| Phathumwan | Thailand |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| 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. | Mean | Standard Deviation | Centimeter of water |
|
|
|
| Secondary | Maximal Cystometric Capacity (MCC) | MCC represents the maximum volume of urine the bladder holds. | ITT population. | Posted | Mean | Standard Deviation | Milliliter (ml) | Baseline and Week 12 |
|
|
|
| Secondary | 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. | Data for this outcome measure is not reported because the data was not collected and included in Case Report Form (CRF). | Posted | Baseline and Week 12 |
|
|
| Secondary | Post-Void Residual Urine Volume | Post-void residual urine volume is the amount of urine remaining in the bladder after void completion. | ITT population. Here "N" (number of participants analyzed) signifies participants who were evaluable for this measure and "n" signifies participants who were evaluable for this measure at a particular time point. | Posted | Mean | Standard Error | Milliliter (ml) | Baseline and Week 12 |
|
|
|
| Secondary | Reflex Volume | Reflex volume is the infused volume that induces the first detrusor contraction. | Data for this outcome measure is not reported because the data was not collected and included in Case Report Form (CRF). | Posted | Baseline and Week 12 |
|
|
| Secondary | 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. | ITT population. Here "n" signifies participants who were evaluable for this measure at a particular time point. | Posted | Mean | Standard Deviation | Episodes | Baseline, Week 4 and Week 12 |
|
|
|
| Secondary | Total Incontinence Episodes | Episodes of total urinary incontinence were reported. Urinary incontinence is the complaint of any involuntary leakage of urine. | ITT population. Here "n" signifies participants who were evaluable for this measure at a particular time point. This study is early terminated and there were some missing data for total incontinence which lead to decrease value of total incontinence. | Posted | Mean | Standard Deviation | Episodes | Baseline, Week 4 and Week 12 |
|
|
|
| Secondary | 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. | Data was not reported for this OM, as data was not analyzed because of change in the planned analysis of the study. | Posted | Baseline, Week 4 and Week 12 |
|
|
| Secondary | 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. | ITT population. Here "N" signifies participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 12 |
|
|
|
| 1 |
| 15 |
| 12 |
| 15 |
| Dry mouth | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 7.1 | Non-systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 7.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Cystitis | Renal and urinary disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Vomitting | Gastrointestinal disorders | MedDRA 7.1 | Non-systematic Assessment |
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| Nerve compression | Injury, poisoning and procedural complications | MedDRA 7.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 7.1 | Non-systematic Assessment |
|
Sponsor shall have first to present the data of Clinical Trial (CT) without approval from the Institution or PI. If the Institution and PI wish to publish data from CT, a copy of the same must be provided to Sponsor for review at least 60 days prior to submission. No paper with Confidential Information will be submitted with Sponsor's prior written consent. If requested in writing, Institution and PI will withhold publication for up to an additional 60 days to allow filing of patent application.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014555 | Urination Disorders |
| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Baseline: Physical Limitations |
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| Baseline: Social Limitations |
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| Baseline: Personal Relationships |
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| Baseline: Emotions |
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| Baseline: Sleep or Energy |
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| Baseline: Incontinence Severity |
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| Week 12: General Health Perceptions |
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| Week 12: Impact of Life |
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| Week 12: Role Limitations |
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| Week 12: Physical Limitations |
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| Week 12: Social Limitations |
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| Week 12: Personal Relationships |
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| Week 12: Emotions |
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| Week 12: Sleep or Energy |
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| Week 12: Incontinence Severity |
|