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

Phase 4

Completed

• Conditions: Overactive Bladder
• Interventions: Drug: trospium chloride; Drug: oxybutynin IR; Drug: oxybutynin IR placebo

• Registration Number: NCT01178827
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-09
• Study First Submitted QC: 2010-08-09
• Study First Posted: 2010-08-10
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-03-23
• Results First Submitted QC: 2012-07-10
• Results First Posted: 2012-08-16
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Patient presents symptoms of overactive bladder
• Patient has age associated memory impairment
• No acute or unstable medical conditions

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sanctura XR®	trospium chloride	Sanctura XR® (trospium chloride), 60mg once daily for 10 days
Oxybutynin IR	oxybutynin IR	Oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days
Oxybutynin IR placebo	oxybutynin IR placebo	Oxybutynin IR placebo three times daily for 2 days

Primary Outcome Measures

Name	Time	Method
Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose	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.
Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose	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®.

Secondary Outcome Measures

Name	Time	Method
Plasma Levels of Sanctura XR® at Day 10 Post-dose	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.
Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose	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.
Change From Baseline in Total Recall Score as Measured by the Hopkins Verbal Learning Test-Revised (HVLT-R) up to Day 10	Baseline, 10 Days	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.
Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10	Baseline, 10 Days	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.
Change From Baseline in Total Recall Score as Measured by the Brief Visuospatial Memory Test-Revised (BVMT-R) up to Day 10	Baseline, 10 Days	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.
Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10	Baseline, 10 Days	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.