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

Purpose

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.

Condition	Intervention	Phase
Overactive Bladder	Drug: trospium chloride Drug: oxybutynin IR Drug: oxybutynin IR placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Memory Overactive Bladder

Drug Information available for: Oxybutynin chloride Oxybutynin Chlorine Trospium chloride Trospium

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose [ Time Frame: Day 10 Post-Dose ] [ Designated as safety issue: No ]
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®.
Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose [ Time Frame: Day 2 Post-Dose ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Plasma Levels of Sanctura XR® at Day 10 Post-dose [ Time Frame: Day 10 Post-Dose ] [ Designated as safety issue: No ]
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 [ Time Frame: Day 2 Post-Dose ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, 10 Days ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, 10 Days ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, 10 Days ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline, 10 Days ] [ Designated as safety issue: No ]
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.

Enrollment:	20
Study Start Date:	August 2010
Study Completion Date:	March 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01178827

Locations

United States, Utah

Salt Lake City, Utah, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan
ClinicalTrials.gov Identifier:	NCT01178827 History of Changes
Other Study ID Numbers:	MA-SXR-09-005
Study First Received:	August 9, 2010
Results First Received:	March 23, 2012
Last Updated:	July 10, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Oxybutynin
Trospium chloride
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013