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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00170768
• Other study ID #: CDAR328A2403
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: January 18, 2008
• Start date: February 2005
• Est. completion date: May 2005

Study information

• Verified date: January 2008
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 2005
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Darifenacin
Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily
• Oxybutynin
Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily
• Placebo
Placebo once daily tablet (sham titration)

Locations

Country	Name	City	State
United States	Washington Neuropsychological Institute LLC Georgetown	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.
Secondary	Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 1 & 2.
Secondary	Effects on other cognitive domains measured by various tests at week 1,2 and 3.