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

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

January 18, 2008

Start Date ^ICMJE

February 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00170768 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Healthy Volunteers

Intervention ^ICMJE

Drug: Darifenacin
Drug: Oxybutynin
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Darifenacin
Active Comparator: Oxybutynin
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

May 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

60 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00170768

Responsible Party

External Affairs, Novartis

Study ID Numbers ^ICMJE

CDAR328A2403

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Novartis

East Hanover NJ

Information Provided By

Novartis

Verification Date

January 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP