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The primary objective of the double-blind phase of the study is to compare the effects of two doses of oxybutynin gel to placebo gel. The objective of the open-label extension is to evaluate the extended safety and skin-irritation profile of topically administered oxybutynin gel.
The hypothesis is that topically administered oxybutynin gel will decrease (compared to placebo) the number of incontinence episodes per week, average daily urinary frequency, and urinary urgency; increase average urinary void volume; and improve patient quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxybutynin Gel 56 mg/day | Experimental |
| |
| Oxybutynin Gel 84 mg/day | Experimental |
| |
| Placebo Gel | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin | Drug | Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12 | Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | 35233 | United States | |||
Baseline period was 1 week. Patients on OAB drugs had to wash out.
Recruitment in clinical sites (urologists mainly) started in September 2007 and was terminated in February 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxybutynin Gel 56 mg/Day | |
| FG001 | Oxybutynin Gel 84 mg/Day | |
| FG002 | Placebo Gel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Placebo | Drug | Placebo Gel Oxybutynin Gel. Transdermal gel was applied once-daily (in the morning) during 12 weeks of treatment. Evaluation: reduction of incontinent episodes (baseline vs 12 weeks); comparison 56 resp. 84 mg vs placebo |
|
|
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| Laguna Hills | California | 92653 | United States |
| Los Angeles | California | 90048 | United States |
| San Diego | California | 92103 | United States |
| San Diego | California | 92120 | United States |
| Farmington | Connecticut | 06032 | United States |
| New Britain | Connecticut | 06052 | United States |
| New Port Richey | Florida | 34625 | United States |
| North Miami | Florida | 33161 | United States |
| Pembroke Pines | Florida | 33024 | United States |
| Sarasota | Florida | 34232 | United States |
| St. Petersburg | Florida | 33710 | United States |
| Tampa | Florida | 33607 | United States |
| Wellington | Florida | 33414 | United States |
| Columbus | Georgia | 31904 | United States |
| Sandy Springs | Georgia | 30328 | United States |
| Stockbridge | Georgia | 30281 | United States |
| Evanston | Illinois | 60201 | United States |
| West Des Moines | Iowa | 50266 | United States |
| Shreveport | Louisiana | 71106 | United States |
| Annapolis | Maryland | 21401 | United States |
| Towson | Maryland | 21204 | United States |
| Watertown | Massachusetts | 02472 | United States |
| Grand Rapids | Michigan | 49503 | United States |
| Saginaw | Michigan | 48604 | United States |
| Chesterfield | Missouri | 63017 | United States |
| Las Vegas | Nevada | 89130 | United States |
| Brooklyn | New York | 11211 | United States |
| Endwell | New York | 13760 | United States |
| Kingston | New York | 12401 | United States |
| Poughkeepsie | New York | 12601 | United States |
| Williamsville | New York | 14221 | United States |
| Cary | North Carolina | 27518 | United States |
| Charlotte | North Carolina | 28209 | United States |
| Harrisburg | North Carolina | 28075 | United States |
| Raleigh | North Carolina | 27607 | United States |
| Raleigh | North Carolina | 27609 | United States |
| Salisbury | North Carolina | 28144 | United States |
| Wilmington | North Carolina | 28401 | United States |
| Winston-Salem | North Carolina | 27103 | United States |
| Wadsworth | Ohio | 44218 | United States |
| Bethany | Oklahoma | 73008 | United States |
| Corvallis | Oregon | 97330 | United States |
| Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Landsdale | Pennsylvania | 19446 | United States |
| Greenville | South Carolina | 29615 | United States |
| Mt. Pleasant | South Carolina | 29464 | United States |
| Myrtle Beach | South Carolina | 29572 | United States |
| Sioux Falls | South Dakota | 57104 | United States |
| Fayetteville | Tennessee | 37334 | United States |
| Provo | Utah | 84604 | United States |
| Richmond | Virginia | 23294 | United States |
| Seattle | Washington | 98104 | United States |
| Spokane | Washington | 99207 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxybutynin Gel 56 mg/Day | |
| BG001 | Oxybutynin Gel 84 mg/Day | |
| BG002 | Placebo Gel | |
| BG003 | 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 |
| ||||||||||||||||
| Number of incontinent episodes at baseline | Mean | Standard Deviation | Episodes |
|
| 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 | Change From Baseline in Mean Weekly Frequency of Urinary Incontinence Episodes at Week 12 | Reduction in number of incontinent episodes, evaluated as mITT (modified intention to treat), after 12 weeks of treatment compared to baseline. | mITT (modified intended to treatment) per protocol Difference between Baseline and after 12 weeks treatment | Posted | Mean | Standard Deviation | Episodes | 12 weeks |
|
|
|
Throughout whole study (20 months)
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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 Gel 56 mg/Day | 3 | 210 | 98 | 210 | |||
| EG001 | Oxybutynin Gel 84 mg/Day | 4 | 214 | 90 | 214 | |||
| EG002 | Placebo Gel | 2 | 202 | 53 | 202 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Abortion missed | Reproductive system and breast disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Chest pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Hepatic neoplasm malignant | Hepatobiliary disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA (11.0) | Systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | MedDRA (11.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Diarrhoe | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Application site reaction | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Application site erythema | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Application site rash | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Application site pruritus | General disorders | MedDRA (11.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kaushik Dave | Antares Pharma | 609 359 3020 | kdave@antarespharma.com |
| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| 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 |
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| 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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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|