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Completed

NCT Number: NCT01178827

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.

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Key information

Conditions

Overactive Bladder Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Salt Lake City, Utah, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trospium Chloride

Drug

trospium chloride (60mg) once daily for 10 days

Other names: Sanctura XR®

oxybutynin IR

Drug

oxybutynin IR (5 mg) three times daily for 2 days

oxybutynin IR placebo

Drug

oxybutynin IR placebo three times daily for 2 days

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 10, 2010
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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