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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-dose

Cerebral 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-dose

Plasma 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

Page last updated: August 23, 2015

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