Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
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ClinicalTrials.gov Identifier: NCT00863551 |
Recruitment Status :
Completed
First Posted : March 18, 2009
Results First Posted : December 19, 2011
Last Update Posted : February 26, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Elderly Pharmacokinetics Overactive Bladder | Drug: Trospium Chloride | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 12 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | April 2009 |
Actual Primary Completion Date : | August 2009 |
Actual Study Completion Date : | August 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: Trospium Chloride Extended Release, 60 mg
Trospium Chloride Extended Release, 60 mg
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Drug: Trospium Chloride
Extended release, 60 mg, oral daily
Other Name: Sanctura XR™ 60 mg |
- Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5 [ Time Frame: Day 10, Hour 5 ]Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.
- Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose [ Time Frame: 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).
- Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function Delayed Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) at Day 10 Post-Dose [ Time Frame: 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 trial. The delayed recall score provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory).
- Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Total Score at Day 10 Post-Dose [ Time Frame: 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). Due to technical problems associated with the administration of the test, the results were invalid.
- Percentage of Study Subjects With No Clinically Significant Effect on Neurocognitive Function as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) Delayed Recall Score at Day 10 Post-Dose [ Time Frame: 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 a yes/no delayed recognition trial. The delayed recall score, derived from the delayed recall trial, provides a measure of the patient's recent memory. The total score ranges from 0 (no memory) to 12 (best memory). Due to technical problems associated with the administration of the test, the results were invalid.

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Ages Eligible for Study: | 65 Years to 75 Years (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female, 65-75 years of age without evidence of memory impairment
- Subject has overactive bladder symptoms but otherwise healthy
- Non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit)
- Weight within normal range
- Ability to follow study instructions and likely to complete all required visits
Exclusion Criteria:
- Residual urine within bladder greater than 4 ounces
- Moderate or severe memory impairment
- Bleeding disorder
- Blood-thinning agents
- Concurrent overactive bladder medication
- Concurrent dementia drugs: Aricept (donepezil), Namenda (memantine), Cognex (tacrine), Exelon (rivastigmine), Razadyne (galantamine), galantamine or similar drugs for dementia
- Chronic kidney failure
- Abdominal bypass surgery for obesity

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863551
United States, California | |
Glendale, California, United States |
Study Director: | Medical Director | Allergan |
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT00863551 |
Other Study ID Numbers: |
MA-SXR-09-001 SMART Trial ( Other Identifier: Allergan ) |
First Posted: | March 18, 2009 Key Record Dates |
Results First Posted: | December 19, 2011 |
Last Update Posted: | February 26, 2016 |
Last Verified: | January 2016 |
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Trospium chloride Parasympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Urological Agents |