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This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder.
This study will use a multicenter, randomized, open-label, active-controlled, dose-titration, parallel group design, in approximately pediatric patients with detrusor overactivity associated with a neurological condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxybutynin Transdermal System | Experimental | Oxybutynin Transdermal System 1.3 mg/day, 2.6 mg/day, or 3.9 mg/day |
|
| Oral oxybutynin | Active Comparator | 5 to 15 mg/day immediate release or extended release tablets, or syrup |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin | Drug | 1.3, 2.6, 3.9 mg/day transdermal |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Catheterization Urine Volume | Change from baseline in average volume of urine collected by catheterization | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Catheterizations Without Leakage | Percentage of catherizations without leakage | 14 weeks |
| Urine Volume After First Awakening | Change from baseline in average volume of urine collected after first morning awakening |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Hoel, RPh, PhD | Watson Laboratories, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Watson Investigational Site | Little Rock | Arkansas | United States | |||
| Watson Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19683731 | Result | Cartwright PC, Coplen DE, Kogan BA, Volinn W, Finan E, Hoel G. Efficacy and safety of transdermal and oral oxybutynin in children with neurogenic detrusor overactivity. J Urol. 2009 Oct;182(4):1548-54. doi: 10.1016/j.juro.2009.06.058. Epub 2009 Aug 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxybutynin TDS | Oxybutynin Transdermal System |
| FG001 | Oral Oxybutynin | Oxybutynin tablets |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Titration Period |
|
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| Oxybutynin | Drug | 5 to 15 mg/day immediate release or extended release tablets, or syrup |
|
|
| 14 weeks |
| Orange County |
| California |
| United States |
| Watson Investigational Site | San Diego | California | United States |
| Watson Investigational Site | Denver | Colorado | United States |
| Watson Investigational Site | Washington D.C. | District of Columbia | United States |
| Watson Investigational Site | Detroit | Michigan | United States |
| Watson Investigational Site | Minneapolis | Minnesota | United States |
| Watson Investigational Site | Jackson | Mississippi | United States |
| Watson Investigational Site | Kansas City | Missouri | United States |
| Watson Investigational Site | St Louis | Missouri | United States |
| Watson Investigational Site | Voorhees Township | New Jersey | United States |
| Watson Investigational Site | Albany | New York | United States |
| Watson Investigational Site | Buffalo | New York | United States |
| Watson Investigational Site | Poughkeepsie | New York | United States |
| Watson Investigational Site | Ashville | North Carolina | United States |
| Watson Investigational Site | Durham | North Carolina | United States |
| Watson Investigational Site | Columbus | Ohio | United States |
| Watson Investigational Site | Oklahoma City | Oklahoma | United States |
| Watson Investigational Site | Hershy | Pennsylvania | United States |
| Watson Investigational Site | Dallas | Texas | United States |
| Watson Investigational Site | Houston | Texas | United States |
| Watson Investigational Site | Plano | Texas | United States |
| Watson Investigational Site | Salt Lake City | Utah | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Maintenance Period |
|
|
| Follow-Up Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxybutynin TDS | Oxybutynin Transdermal System |
| BG001 | Oral Oxybutynin | Oxybutynin tablets |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Average Catheterization Urine Volume | Change from baseline in average volume of urine collected by catheterization | Modified intent-to-treat (mITT) population, Last Observation Carried Forward (LOCF) imputation | Posted | 2009 | Mean | Standard Deviation | mL | 14 weeks |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Catheterizations Without Leakage | Percentage of catherizations without leakage | mITT, LOCF | Posted | Sep 2009 | Mean | Standard Deviation | % of participants | 14 weeks |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Urine Volume After First Awakening | Change from baseline in average volume of urine collected after first morning awakening | Not Posted | Mean | Standard Deviation | mL | 14 weeks |
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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 TDS | Oxybutynin Transdermal System | 6 | 39 | 33 | 39 | ||
| EG001 | Oral Oxybutynin | Oxybutynin tablets | 3 | 16 | 12 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergic reaction | General disorders | COSTART | Non-systematic Assessment |
| |
| Knee wound dehiscence | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Worsening abdominal pain | General disorders | COSTART | Non-systematic Assessment |
| |
| Thrombophlebitis | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| VP shunt malfunction | Nervous system disorders | COSTART | Non-systematic Assessment |
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| Worsening dehydration | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Fever | General disorders | COSTART | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Tethered cord | Musculoskeletal and connective tissue disorders | COSTART | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | COSTART | Non-systematic Assessment |
| |
| Headache | General disorders | COSTART | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | COSTART | Non-systematic Assessment |
| |
| Infection | Infections and infestations | COSTART | Non-systematic Assessment |
| |
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Pain abdominal | General disorders | COSTART | Non-systematic Assessment |
| |
| Pain back | General disorders | COSTART | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Pruritis | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Rhinitis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Pain | General disorders | COSTART | Non-systematic Assessment |
|
The transdermal groups included more males and younger subjects. The study was not designed to compare the transdermal and oral groups. Advserse event data reported for the titration and maintenance periods.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Hoel, RPh, PhD, Executive Director of Clinical Research | Watson Laboratories, Inc | 801-588-6641 | gary.hoel@watson.com |
| ID | Term |
|---|---|
| C005419 | oxybutynin |
| D000068737 | Tolterodine Tartrate |
| ID | Term |
|---|---|
| D010665 | Phenylpropanolamine |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003408 | Cresols |
| D010636 | Phenols |
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| >=65 years |
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| Male |
|
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