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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Elderly
Pharmacokinetics
Overactive Bladder
Intervention Drug: Trospium Chloride
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Trospium Chloride Extended Release, 60 mg
Hide Arm/Group Description Trospium Chloride Extended Release, 60 mg
Period Title: Overall Study
Started 12
Completed 12
Not Completed 0
Arm/Group Title Trospium Chloride Extended Release, 60 mg
Hide Arm/Group Description Trospium Chloride Extended Release, 60 mg
Overall Number of Baseline Participants 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 12 participants
68
(65 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants
Female
7
  58.3%
Male
5
  41.7%
1.Primary Outcome
Title Cerebral Spinal Fluid Levels of Trospium at Day 10, Hour 5
Hide Description Cerebral spinal fluid levels of Trospium at day 10, hour 5. Cerebral spinal fluid was collected from each patient.
Time Frame Day 10, Hour 5
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, which included all patients who started the study.
Arm/Group Title Trospium Chloride Extended Release, 60 mg
Hide Arm/Group Description:
Trospium Chloride Extended Release, 60 mg
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: Picograms per milliliter (pg/mL)
NA [1]   (NA)
[1]
The data were below the limit of quantitation (BLQ).
2.Secondary Outcome
Title 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
Hide Description 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).
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, which included all patients who started the study.
Arm/Group Title Trospium Chloride Extended Release, 60 mg
Hide Arm/Group Description:
Trospium Chloride Extended Release, 60 mg
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Percentage of Subjects
100
3.Secondary Outcome
Title 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
Hide Description 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).
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, which included all patients who started the study.
Arm/Group Title Trospium Chloride Extended Release, 60 mg
Hide Arm/Group Description:
Trospium Chloride Extended Release, 60 mg
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Percentage of Subjects
91.7
4.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.
Arm/Group Title Trospium Chloride Extended Release, 60 mg
Hide Arm/Group Description:
Trospium Chloride Extended Release, 60 mg
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Percentage of Subjects
NA [1] 
[1]
Due to technical problems associated with the administration of the test, the results were invalid.
5.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat, which included all patients who started the study. Due to technical problems associated with the administration of the test, the results were invalid.
Arm/Group Title Trospium Chloride Extended Release, 60 mg
Hide Arm/Group Description:
Trospium Chloride Extended Release, 60 mg
Overall Number of Participants Analyzed 12
Measure Type: Number
Unit of Measure: Percentage of Subjects
NA [1] 
[1]
Due to technical problems associated with the administration of the test, the results were invalid.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Trospium Chloride Extended Release, 60 mg
Hide Arm/Group Description Trospium Chloride Extended Release, 60 mg
All-Cause Mortality
Trospium Chloride Extended Release, 60 mg
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Trospium Chloride Extended Release, 60 mg
Affected / at Risk (%)
Total   0/12 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Trospium Chloride Extended Release, 60 mg
Affected / at Risk (%)
Total   10/12 (83.33%) 
Gastrointestinal disorders   
Nausea *  3/12 (25.00%) 
Vomiting *  3/12 (25.00%) 
Constipation *  2/12 (16.67%) 
Dry Mouth *  2/12 (16.67%) 
Flatulence *  2/12 (16.67%) 
General disorders   
Change in taste *  1/12 (8.33%) 
Metabolism and nutrition disorders   
Increased appetite *  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders   
Low back pain *  2/12 (16.67%) 
Nervous system disorders   
Headache *  7/12 (58.33%) 
Psychiatric disorders   
Anxiety *  1/12 (8.33%) 
Skin and subcutaneous tissue disorders   
Folliculitis   1/12 (8.33%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Due to technical problems associated with the administration of the BVMT-R test, the results were invalid, therefore, results for Outcome Measures 4 and 5 are not presented.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Medical Affairs
Organization: Allergan, Inc.
Phone: 714-246-4500
EMail: clinicaltrials@allergan.com
Layout table for additonal information
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT00863551    
Other Study ID Numbers: MA-SXR-09-001
SMART Trial ( Other Identifier: Allergan )
First Submitted: March 16, 2009
First Posted: March 18, 2009
Results First Submitted: November 16, 2011
Results First Posted: December 19, 2011
Last Update Posted: February 26, 2016