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A new drug for overactive bladder is compared to placebo to determine if it is safe and effective. The study lasts approximately 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxybutynin topical gel | Experimental | Oxybutynin topical gel |
|
| Placebo topical gel | Placebo Comparator | placebo topical gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin topical gel | Drug | 1 application daily to skin for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Average Number of Daily Incontinence Episodes | Average number of daily incontinence episodes at baseline | Baseline |
| Change From Baseline in Average Daily Number of Incontinence Episodes | Change from Baseline to Week 12 in average daily number of incontinence episodes | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Average Daily Urinary Frequency | Number of daily urinary voids | Baseline |
| Change From Baseline in Average Daily Urinary Frequency | Change from baseline in average daily urinary frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Caramelli, MS | Watson Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19233423 | Result | Staskin DR, Dmochowski RR, Sand PK, Macdiarmid SA, Caramelli KE, Thomas H, Hoel G. Efficacy and safety of oxybutynin chloride topical gel for overactive bladder: a randomized, double-blind, placebo controlled, multicenter study. J Urol. 2009 Apr;181(4):1764-72. doi: 10.1016/j.juro.2008.11.125. Epub 2009 Feb 23. | |
| 37160401 | Derived |
| Label | URL |
|---|---|
| Drugs@FDA | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxybutynin Topical Gel | 1 g Oxybutynin topical gel |
| FG001 | Placebo Topical Gel | 1 g placebo topical gel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo topical gel | Other | 1 application daily to skin for 12 weeks |
|
|
| Baseline to 12 weeks |
| Baseline Average Urine Void Volume | Baseline average urine void volume | Baseline |
| Change From Baseline in Average Urine Void Volume | Change from baseline to Week 12 in average urine void volume | Change from Baseline to Week 12 |
| Homewood |
| Alabama |
| United States |
| Mobile | Alabama | United States |
| Montgomery | Alabama | United States |
| Phoenix | Arizona | United States |
| Tucson | Arizona | United States |
| Little Rock | Arkansas | United States |
| Anaheim | California | United States |
| Buena Park | California | United States |
| Laguna Woods | California | United States |
| Sacramento | California | United States |
| San Diego | California | United States |
| Torrance | California | United States |
| Denver | Colorado | United States |
| Waterbury | Connecticut | United States |
| Aventura | Florida | United States |
| Clearwater | Florida | United States |
| DeLand | Florida | United States |
| Leesburg | Florida | United States |
| Ocala | Florida | United States |
| Plantation | Florida | United States |
| Tallahassee | Florida | United States |
| West Palm Beach | Florida | United States |
| Alpharetta | Georgia | United States |
| Atlanta | Georgia | United States |
| Belville | Illinois | United States |
| Chicago | Illinois | United States |
| Melrose Park | Illinois | United States |
| Evansville | Indiana | United States |
| South Bend | Indiana | United States |
| Shreveport | Louisiana | United States |
| Watertown | Massachusetts | United States |
| Saginaw | Michigan | United States |
| Saint Joseph | Michigan | United States |
| Omaha | Nebraska | United States |
| Las Vegas | Nevada | United States |
| Albuquerque | New Mexico | United States |
| Albany | New York | United States |
| Garden City | New York | United States |
| New York | New York | United States |
| Williamsville | New York | United States |
| Winston-Salem | North Carolina | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Lyndhurst | Ohio | United States |
| Bethany | Oklahoma | United States |
| Edmond | Oklahoma | United States |
| Portland | Oregon | United States |
| Allentown | Pennsylvania | United States |
| Newton | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| West Reading | Pennsylvania | United States |
| Warwick | Rhode Island | United States |
| Greer | South Carolina | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| Corpus Christi | Texas | United States |
| Dallas | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| Richmond | Virginia | United States |
| Spokane | Washington | United States |
| Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3. |
| Watson Pharma product webpage | View source |
| COMPLETED |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxybutynin Topical Gel | 1 g Oxybutynin topical gel |
| BG001 | Placebo Topical Gel | 1 g placebo topical gel |
| 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 | Baseline Average Number of Daily Incontinence Episodes | Average number of daily incontinence episodes at baseline | Posted | Jan 2010 | Mean | Standard Deviation | Number of episodes | Baseline |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Baseline Average Daily Urinary Frequency | Number of daily urinary voids | Posted | Jan 2010 | Mean | Standard Deviation | Number of urinary episodes | Baseline |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Average Daily Urinary Frequency | Change from baseline in average daily urinary frequency | Posted | Jan 2010 | Mean | Standard Deviation | Number of urinary episodes | Baseline to 12 weeks |
|
| |||||||||||||||||||||||||||||
| Primary | Change From Baseline in Average Daily Number of Incontinence Episodes | Change from Baseline to Week 12 in average daily number of incontinence episodes | Posted | Jan 2010 | Mean | Standard Deviation | Number of episodes | Baseline to Week 12 |
|
| |||||||||||||||||||||||||||||
| Secondary | Baseline Average Urine Void Volume | Baseline average urine void volume | Posted | Jan 2010 | Mean | Standard Deviation | mL | Baseline |
|
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Average Urine Void Volume | Change from baseline to Week 12 in average urine void volume | Posted | Jan 2010 | Mean | Standard Deviation | mL | Change from Baseline to Week 12 |
|
|
12 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 Topical Gel | 1 g Oxybutynin topical gel | 7 | 389 | 176 | 389 | ||
| EG001 | Placebo Topical Gel | 1 g placebo topical gel | 10 | 400 | 145 | 400 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Labyrinthitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Multiple myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Ovarian adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Renal hemmorrhage | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site pruritis | General disorders | MedDRA | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Gastroenteritis viral | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Hoel, PhD, Executive Director | Watson Laboratories, Inc | 801-808-8866 | gary.hoel@watson.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| 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 |
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
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| ID | Term |
|---|---|
| C005419 | oxybutynin |
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| >=65 years |
|
| Male |
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