NCT01178827

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 16, 2012

Completed
Last Updated

February 26, 2016

Status Verified

January 1, 2016

Enrollment Period

7 months

First QC Date

August 9, 2010

Results QC Date

March 23, 2012

Last Update Submit

January 28, 2016

Conditions

Overactive Bladder

Outcome Measures

Primary Outcomes (2)

  • Cerebral Spinal Fluid Levels of Sanctura XR® at 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®.

    Day 10 Post-Dose

  • Cerebral Spinal Fluid Levels of Oxybutynin and N-Desethyl-Oxybutynin at 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.

    Day 2 Post-Dose

Secondary Outcomes (6)

  • Plasma Levels of Sanctura XR® at Day 10 Post-dose

    Day 10 Post-Dose

  • Plasma Levels of Oxybutynin and N-Desethyl-Oxybutynin at Day 2 Post-dose

    Day 2 Post-Dose

  • 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 Delayed Recall Score as Measured by the HVLT-R up to Day 10

    Baseline, 10 Days

  • 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

  • +1 more secondary outcomes

Study Arms (3)

Sanctura XR®

EXPERIMENTAL

Sanctura XR® (trospium chloride), 60mg once daily for 10 days

Drug: trospium chloride

Oxybutynin IR

ACTIVE COMPARATOR

Oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days

Drug: oxybutynin IR

Oxybutynin IR placebo

PLACEBO COMPARATOR

Oxybutynin IR placebo three times daily for 2 days

Drug: oxybutynin IR placebo

Interventions

trospium chlorideDRUG

trospium chloride (60mg) once daily for 10 days

Also known as: Sanctura XR®
Sanctura XR®
oxybutynin IRDRUG

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

Oxybutynin IR
oxybutynin IR placeboDRUG

oxybutynin IR placebo three times daily for 2 days

Oxybutynin IR placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

trospium chloride

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Vice President Medical Affairs,
Organization
Allergan, Inc
clinicaltrials@allergan.com
714-246-4500

Study Officials

  • Medical Director

    Allergan

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 10, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

February 26, 2016

Results First Posted

August 16, 2012

Record last verified: 2016-01

Locations

US(1)