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

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00170768

Purpose

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

Condition	Intervention	Phase
Healthy Volunteers	Drug: Darifenacin Drug: Oxybutynin Drug: Placebo	Phase II

Drug Information available for: Darifenacin Darifenacin hydrobromide Oxybutynin Oxybutynin chloride

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over

Further study details as provided by Novartis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Arms	Assigned Interventions
1: Experimental Darifenacin	Drug: Darifenacin Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily
2: Active Comparator Oxybutynin	Drug: Oxybutynin Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily
3: Placebo Comparator Placebo	Drug: Placebo Placebo once daily tablet (sham titration)

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170768

Locations

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

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis

East Hanover NJ

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CDAR328A2403
Study First Received:	September 9, 2005
Last Updated:	January 18, 2008
ClinicalTrials.gov Identifier:	NCT00170768
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

Darifenacin, oxybutynin, cognition, memory

Study placed in the following topic categories:

Oxybutynin
Darifenacin
Healthy

Additional relevant MeSH terms:

Muscarinic Antagonists
Parasympatholytics
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists

Autonomic Agents
Physiological Effects of Drugs
Peripheral Nervous System Agents
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009