Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Overactive Bladder
Intervention: trospium chloride (Drug); oxybutynin IR (Drug); oxybutynin IR placebo (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Allergan
Summary
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-doseCerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose
Secondary outcome: Plasma Levels of Sanctura XR® at Day 10 Post-dosePlasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at 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 Delayed Recall Score as Measured by the HVLT-R up to Day 10 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 Delayed Recall Score as Measured by the BVMT-R up to Day 10
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient presents symptoms of overactive bladder
- Patient has age associated memory impairment
- No acute or unstable medical conditions
Exclusion Criteria:
- History of alcohol or substance abuse within 1 year prior to study
- Has donated in excess of 500mL of blood or plasma in the 30 days prior to study
- Has known bleeding disorder (hemophilia)
- Previous abdominal bypass surgery for obesity
Locations and Contacts
Salt Lake City, Utah, United States
Additional Information
Starting date: August 2010
Last updated: July 10, 2012
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