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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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