Sanctura Muscarinic Receptor Antagonist Resists Transport (SMART-II) Trial

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.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Drug: trospium chloride; Drug: oxybutynin IR; Drug: oxybutynin IR placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sanctura XR®; Sanctura XR® (trospium chloride), 60mg once daily for 10 days	Drug: trospium chloride; trospium chloride (60mg) once daily for 10 days; Other Names: Sanctura XR®
Active Comparator: Oxybutynin IR; Oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days	Drug: oxybutynin IR; oxybutynin IR (5 mg) three times daily for 2 days
Placebo Comparator: Oxybutynin IR placebo; Oxybutynin IR placebo three times daily for 2 days	Drug: oxybutynin IR placebo; oxybutynin IR placebo three times daily for 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose	Cerebral spinal fluid levels of Sanctura XR® at Day 10 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Sanctura XR®.	Day 10 Post-Dose
Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose	Cerebral spinal fluid levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 Post-dose. Cerebral spinal fluid is the fluid that surrounds the spinal cord and the inside of the brain. Samples were drawn from patients who received Oxybutynin IR.	Day 2 Post-Dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Levels of Sanctura XR® at Day 10 Post-dose	Plasma levels of Sanctura XR® at Day 10 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.	Day 10 Post-Dose
Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose	Plasma levels of Oxybutynin and N-Desethyl-Oxybutynin (metabolite of Oxybutynin) at Day 2 post-dose. Plasma is the liquid component of the blood in which the blood cells are suspended. Plasma samples were collected from each patient and analyzed for the drug the patient received.	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 Total Recall Score as Measured by the HVLT-R up to 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). A positive change from baseline indicates improved memory and a negative change from baseline indicates worsened memory.	Baseline, 10 Days
Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10	Change from Baseline in Delayed Recall Score as Measured by the HVLT-R up to 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 12 (best memory). A positive change from baseline indicates improved memory.	Baseline, 10 Days
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 total recall score as measured by the BVMT-R up to 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 36 (best memory). A positive change from baseline indicates improved memory.	Baseline, 10 Days
Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10	Change from Baseline in delayed recall score as measured by the BVMT-R up to 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). A positive change from baseline indicates improved memory.	Baseline, 10 Days

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: August 9, 2010
• First Submitted That Met QC Criteria: August 9, 2010
• First Posted (Estimate): August 10, 2010

Study Record Updates

• Last Update Posted (Estimate): February 26, 2016
• Last Update Submitted That Met QC Criteria: January 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Anti-Infective Agents, Urinary; Renal Agents; Oxybutynin; Trospium chloride; Mandelic Acids
• Other Study ID Numbers: MA-SXR-09-005