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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01178827
First received: August 9, 2010
Last updated: July 10, 2012
Last verified: July 2012
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Lower Urinary Tract Symptoms
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
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014