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Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863551
Recruitment Status : Completed
First Posted : March 18, 2009
Results First Posted : December 19, 2011
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE March 16, 2009
First Posted Date  ICMJE March 18, 2009
Results First Submitted Date  ICMJE November 16, 2011
Results First Posted Date  ICMJE December 19, 2011
Last Update Posted Date February 26, 2016
Study Start Date  ICMJE April 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2009)
Mean concentration of trospium in cerebral spinal fluid at day 10, hour 5 [ Time Frame: 5 hr ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2011)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2009)
  • The proportion of study subjects with no clinically significant effect on neurocognitive function as measured by the Hopkins Verbal Learning test-Revised [ Time Frame: Reliable change index between baseline (day 0) and day 10 post-dose ]
  • The proportion of study subjects with no clinically significant effect on neurocognitive function as measured by the Brief Visuospatial Memory Test-Revised [ Time Frame: Reliable change index between baseline (day 0) and day 10 post-dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART) Trial
Official Title  ICMJE Not Provided
Brief Summary This study evaluates the penetration through the blood-brain-barrier of trospium chloride at plasma steady state (Day 10) in elderly subjects with overactive bladder symptoms. Trospium levels in cerebrospinal fluid (CSF) and peak and trough plasma levels will be measured. Baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change index to assess if any study subject shows evidence of a clinically and statistically significant change in memory.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Elderly
  • Pharmacokinetics
  • Overactive Bladder
Intervention  ICMJE Drug: Trospium Chloride
Extended release, 60 mg, oral daily
Other Name: Sanctura XR™ 60 mg
Study Arms  ICMJE Experimental: Trospium Chloride Extended Release, 60 mg
Trospium Chloride Extended Release, 60 mg
Intervention: Drug: Trospium Chloride
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2009)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 75 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00863551
Other Study ID Numbers  ICMJE MA-SXR-09-001
SMART Trial ( Other Identifier: Allergan )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Allergan
Original Responsible Party Vice President Medical Affairs, Allergan, Inc.
Current Study Sponsor  ICMJE Allergan
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP