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| ID | Type | Description | Link |
|---|---|---|---|
| Sanctura XR obesity OAB Trial | Other Identifier | Allergan |
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This study evaluated the effectiveness of trospium chloride extended release (XR) in obese female patients with overactive bladder (OAB). Patients received either placebo and trospium chloride XR or placebo only. The study assessed the change from baseline in urinary frequency, urgency, and incontinence for trospium chloride XR versus a placebo-pill. The study was 14 weeks in duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trospium chloride XR 60 mg | Experimental | Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks. |
|
| placebo | Placebo Comparator | Placebo capsule taken orally once daily for 14 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trospium Chloride, Extended Release (XR) | Drug | Trospium chloride extended release 60 mg capsule taken orally once daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Urinary Urgency Incontinence (UUI) | Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement. | Baseline (Week 2), Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Urgency Severity Associated With Toilet Voids | Due to lack of evaluable data, analysis for this outcome measure was not performed. | Baseline (Week 2), Week 14 |
| Percent Change From Baseline in Voided Volume |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| La Mesa | California | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Trospium Chloride XR 60 mg | Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks. |
| FG001 | Placebo | Placebo capsule taken orally once daily for 14 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Trospium Chloride XR 60 mg | Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Percent Change From Baseline in Urinary Urgency Incontinence (UUI) | Patients recorded information about UUI (accidental leakage, urgency associated with void and urgency severity) in a 3-day diary at Baseline (Week 2) and Week 14. The daily average episodes of UUI was the sum of all UUI episodes over valid diary days during the 3-day diary period divided by the valid number of diary days with at least one valid bladder entry. The percent change from baseline was calculated as (Mean UUI at Week 14- Mean UUI at Week 2)/ Mean UUI at Week 2 X 100. A negative number percent change from baseline indicated an improvement. | Modified Intent-to-Treat (mITT) defined as all patients who were randomized and received at least one dose of study medication. Analysis below was done on patients from the mITT population who completed the study at Week 14 and who had data available for this outcome measure. | Posted | Mean | Standard Deviation | Percent change | Baseline (Week 2), Week 14 |
|
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The safety population was used to calculate the number of participants at risk for Serious Adverse Events and Adverse Events and was defined as all randomized and treated participants.
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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 | Trospium Chloride XR 60 mg | Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment | Event occurred prior to randomization to study medication. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | General disorders | Non-systematic Assessment |
Due to lack of evaluable data, analysis for the secondary outcome measures was not performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C003330 | trospium chloride |
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| placebo | Other | Placebo capsule taken orally once daily for either 2 weeks or 14 weeks. |
|
Due to lack of evaluable data, analysis for this outcome measure was not performed.
| Baseline (Week 2), Week 14 |
| Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score | Due to lack of evaluable data, analysis for this outcome measure was not performed. | Baseline (Week 2), Week 14 |
| Percent Change From Baseline in Percentage of Patients Continent | Due to lack of evaluable data, analysis for this outcome measure was not performed. | Baseline (Week 2), Week 14 |
Placebo capsule taken orally once daily for 14 weeks.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks. |
| OG001 | Placebo | Placebo capsule taken orally once daily for 14 weeks. |
|
|
| Secondary | Percent Change From Baseline in Urgency Severity Associated With Toilet Voids | Due to lack of evaluable data, analysis for this outcome measure was not performed. | Posted | Baseline (Week 2), Week 14 |
|
|
| Secondary | Percent Change From Baseline in Voided Volume | Due to lack of evaluable data, analysis for this outcome measure was not performed. | Posted | Baseline (Week 2), Week 14 |
|
|
| Secondary | Percent Change From Baseline in Over Active Bladder (OAB)-Symptom Composite Score | Due to lack of evaluable data, analysis for this outcome measure was not performed. | Posted | Baseline (Week 2), Week 14 |
|
|
| Secondary | Percent Change From Baseline in Percentage of Patients Continent | Due to lack of evaluable data, analysis for this outcome measure was not performed. | Posted | Baseline (Week 2), Week 14 |
|
|
| 0 |
| 64 |
| 6 |
| 64 |
| EG001 | Placebo | Placebo capsule taken orally once daily for 14 weeks. | 1 | 63 | 3 | 63 |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |