Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over

January 18, 2008 updated by: Novartis
The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20016
        • Washington Neuropsychological Institute LLC Georgetown

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females aged 60 and over
  • United States English as a primary language
  • Given written informed consent by signing and dating an informed consent form prior to study entry

Exclusion Criteria:

  • Current diseases in which the use of anti-cholinergic drugs is contraindicated, including the use of drugs with anti-cholinergic effects
  • Volunteers with history of urinary retention or current bladder outlet obstruction, as determined by the investigator

Other protocol defined inclusion/exclusion criteria may apply.

- Current use of drugs known to effect memory and cognition Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Placebo
Drug: Placebo
Placebo once daily tablet (sham titration)
Experimental: 1
Darifenacin
Drug: Darifenacin
Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily
Other Names:
  • Enablex
Active Comparator: 2
Oxybutynin
Drug: Oxybutynin
Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.

Secondary Outcome Measures

Outcome Measure
Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 1 & 2.
Effects on other cognitive domains measured by various tests at week 1,2 and 3.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Novartis, East Hanover NJ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion (Actual)

May 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

January 23, 2008

Last Update Submitted That Met QC Criteria

January 18, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDAR328A2403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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