Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin...
Brief Summary
Official Title: “Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over”
The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention(s) in this Clinical Trial
- Drug: Darifenacin
- Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily
- Drug: Oxybutynin
- Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily
- Drug: Placebo
- Placebo once daily tablet (sham titration)
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Darifenacin
- Active Comparator: 2
- Oxybutynin
- Placebo Comparator: 3
- Placebo
Outcome Measures for this Clinical Trial
Primary Measures
- Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.
Secondary 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.
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 60 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Study Chair East Hanover NJ
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00170768
Study ID Number: CDAR328A2403
ClinicalTrials.gov Identifier: NCT00170768
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00170768
