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

• ClinicalTrials.gov Identifier: NCT01178827
• Recruitment Status: Completed
• First Posted: August 10, 2010
• Results First Posted: August 16, 2012
• Last Update Posted: February 26, 2016
• Sponsor: Allergan
• Information provided by (Responsible Party): Allergan

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Overactive Bladder	Drug: trospium chloride; Drug: oxybutynin IR; Drug: oxybutynin IR placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Study Start Date: August 2010
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: March 2011

Arms and Interventions

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 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

Outcome Measures

Primary Outcome Measures :

1. Cerebral Spinal Fluid Levels of Sanctura XR® at Day 10 Post-dose [ Time Frame: 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®.
2. Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose [ Time Frame: 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.

Secondary Outcome Measures :

1. Plasma Levels of Sanctura XR® at Day 10 Post-dose [ Time Frame: 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.
2. Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose [ Time Frame: 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.
3. 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 ]
   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.
4. Change From Baseline in Delayed Recall Score as Measured by the HVLT-R up to Day 10 [ Time Frame: 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.
5. 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 ]
   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.
6. Change From Baseline in Delayed Recall Score as Measured by the BVMT-R up to Day 10 [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 60 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Utah

Salt Lake City, Utah, United States

Sponsors and Collaborators

Allergan

Investigators

• Study Director: Medical Director; Allergan

More Information

• Responsible Party: Allergan
• ClinicalTrials.gov Identifier: NCT01178827
• Other Study ID Numbers: MA-SXR-09-005
• First Posted: August 10, 2010
• Results First Posted: August 16, 2012
• Last Update Posted: February 26, 2016
• Last Verified: January 2016

Additional relevant MeSH terms:

Urinary Bladder, Overactive; Urinary Bladder Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Mandelic Acids; Oxybutynin; Trospium chloride; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Anti-Infective Agents, Urinary; Anti-Infective Agents; Renal Agents