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This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sanctura XR® | Experimental | Sanctura XR® (trospium chloride), 60mg once daily for 10 days |
|
| Oxybutynin IR | Active Comparator | Oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days |
|
| Oxybutynin IR placebo | Placebo Comparator | Oxybutynin IR placebo three times daily for 2 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trospium chloride | Drug | trospium chloride (60mg) once daily for 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose | Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®. | Day 10 Post-Dose |
| Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose | Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR. | Day 2 Post-Dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Levels of Sanctura XR® at Day 10 Post-dose | Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received. | Day 10 Post-Dose |
| Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose |
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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 |
|---|---|---|---|---|---|---|
| Salt Lake City | Utah | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sanctura XR® | Sanctura XR® (trospium chloride), 60mg once daily for 10 days |
| FG001 | Oxybutynin IR | Oxybutynin IR (oxybutynin immediate release) 5 mg, three times daily for 2 days |
| FG002 | Oxybutynin IR Placebo | Oxybutynin IR placebo three times daily for 2 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sanctura XR® | Sanctura XR® (60mg) once daily for 10 days |
| BG001 | Oxybutynin IR | Oxybutynin IR (5 mg) three times daily for 2 days |
| 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 | Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose | Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®. | All patients who received Sanctura XR® | Posted | Mean | Standard Deviation | Nanograms (ng) per milliliter (mL) | Day 10 Post-Dose |
|
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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 | Sanctura XR® | Sanctura XR® (60mg) once daily for 10 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry Mouth | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President Medical Affairs, | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C003330 | trospium chloride |
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| oxybutynin IR | Drug | oxybutynin IR (5 mg) three times daily for 2 days |
|
| oxybutynin IR placebo | Drug | oxybutynin IR placebo three times daily for 2 days |
|
Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received. |
| Day 2 Post-Dose |
| Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10 | Change from Baseline in Total Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory. | Baseline, 10 Days |
| Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10 | Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory. | Baseline, 10 Days |
| Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10 | Change from Baseline in total recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory. | Baseline, 10 Days |
| Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10 | Change from Baseline in delayed recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory. | Baseline, 10 Days |
| BG002 | Oxybutynin IR Placebo | Oxybutynin IR placebo three times daily for 2 days |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 |
| Oxybutynin IR Placebo |
Oxybutynin IR placebo three times daily for 2 days |
|
|
| Primary | Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose | Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR. | All patients who received Oxybutynin IR | Posted | Mean | Standard Deviation | Nanograms (ng) per milliliter (mL) | Day 2 Post-Dose |
|
|
|
| Secondary | Plasma Levels of Sanctura XR® at Day 10 Post-dose | Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received. | All patients who received of Sanctura XR® | Posted | Mean | Standard Deviation | Nanograms (ng) per milliliter (mL) | Day 10 Post-Dose |
|
|
|
| Secondary | Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose | Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received. | All patients who received of Oxybutynin IR | Posted | Mean | Standard Deviation | Nanograms (ng) per milliliter (mL) | Day 2 Post-Dose |
|
|
|
| Secondary | Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10 | Change from Baseline in Total Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory. | Per Protocol: All subjects who completed the study. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, 10 Days |
|
|
|
| Secondary | Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10 | Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10. The HVLT-R is an instrument used to measure verbal learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition. The total recall score was the sum of 3 'free recall' learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory. | Per Protocol: All subjects who completed the study. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, 10 Days |
|
|
|
| Secondary | Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10 | Change from Baseline in total recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 36 (best memory). A positive change from baseline indicates improved memory. | Per Protocol: All subjects who completed the study. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, 10 Days |
|
|
|
| Secondary | Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10 | Change from Baseline in delayed recall score as measured by the BVMT-R up to Day 10. The BVMT-R is an instrument used to measure visual learning and memory (recognition and recall). It consists of 3 learning trials: free recall, delayed recall, and yes/no delayed recognition trial. The total recall score is the sum of 3 free recall learning trials, and reflects the patient's ability to learn. The total score ranges from 0 (no memory) to 12 (best memory). A positive change from baseline indicates improved memory. | Per Protocol: All subjects who completed the study. | Posted | Mean | Standard Deviation | Scores on a Scale | Baseline, 10 Days |
|
|
|
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Oxybutynin IR | Oxybutynin IR (5 mg) three times daily for 2 days | 0 | 10 | 7 | 10 |
| EG002 | Oxybutynin IR Placebo | Oxybutynin IR placebo three times daily for 2 days | 0 | 4 | 2 | 4 |
| Dysphagia | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA version 13.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Hypoacusis | Ear and labyrinth disorders | MedDRA version 13.1 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA version 13.1 | Systematic Assessment |
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| Application Site Pruritus | General disorders | MedDRA version 13.1 | Systematic Assessment |
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| Body Temperature Increased | Investigations | MedDRA version 13.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Micturition Urgency | Renal and urinary disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
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| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 13.1 | Non-systematic Assessment |
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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.
| 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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