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| Name | Class |
|---|---|
| Norwich Clinical Research Associates Ltd. | OTHER |
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The purpose of this study is to determine if a new drug treatment is effective for the treatment of symptoms of urinary incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UISH001 | Experimental |
| |
| Matching placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UISH001 | Drug | sublingual dosing, 1 drop 3 times a day |
| |
| matching placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Decrease in Leakage Events of 30% or More. | Incontinence events were recorded on a daily diary. Leaks were scored and tabulated for a daily score. These values were utilized to come up with total of leakage events during the double-blind treatment period. | Change from baseline after 4 weeks of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Clinical Research, Inc. | Endwell | New York | 13760 | United States | ||
| Rochester Clinical Research |
Participants entered a one week placebo run in period to fulfill inclusion/exclusion criteria before being randomized.
Participants were recruited from three medical clinics during the study period of 05/06/2011 to 05/17/2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Run-In | All subjects entered a one week placebo run in period to qualify for the study. |
| FG001 | Placebo | Subjects were randomized at Visit 2 |
| FG002 | UISH001 | Subjects were randomized at Visit 2 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo Run in Period |
|
| ||||||||||||||||||
| 5 Week Double Blind Randomization Period |
|
Baseline characteristics only for subjects that were randomized into the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Matching Placebo | At randomization at visit 2, subjects were treated with matching placebo. |
| BG001 | UISH001 | At randomization at visit 2, subjects were treated with UISH001. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Percentage of Participants With a Decrease in Leakage Events of 30% or More. | Incontinence events were recorded on a daily diary. Leaks were scored and tabulated for a daily score. These values were utilized to come up with total of leakage events during the double-blind treatment period. | Posted | Number | Percentage of participants | Change from baseline after 4 weeks of treatment. |
|
AEs were collected from the time of informed consent to the end of the study (6 weeks)
Subjects were queried concerning AEs at all visits.
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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 | Non-Randomized Subjects | Adverse Events (AEs) captured for subjects that were not randomized |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Fibrillation | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. John McMichael | Beech Tree Labs, Inc. | 518-872-1144 |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014550 | Urinary Incontinence, Stress |
| D053202 | Urinary Incontinence, Urge |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Drug |
sublingual dosing,1 drop 3 times a day |
|
| Rochester |
| New York |
| 14609 |
| United States |
| PEAK Research, LLC | Upper Saint Clair | Pennsylvania | 15241 | United States |
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | UISH001 | Subjects were treated with UISH001 during double blind treatment period. | 1 | 34 | 15 | 34 |
| EG002 | Matching Placebo | Subjects were treated with matching placebo during double blind treatment period. | 0 | 33 | 7 | 33 |
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Upper Respiratory Infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| 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 |