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Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers

Information source: Watson Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: oxybutynin chloride immediate-release (Drug); oxybutynin chloride topical gel (Drug); placebo (Other)

Phase: Phase 1

Status: Completed

Sponsored by: Watson Pharmaceuticals

Summary

The purpose of this study is to explore the possible cognitive effects of oxybutynin tablets and oxybutynin gel.

Clinical Details

Official title: Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Primary outcome: Measure of accuracy of delayed recall name-phase association test

Secondary outcome: Effects on other cognitive domains measured by various tests

Eligibility

Minimum age: 60 Years. Maximum age: 79 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and females aged 60 and over

- 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 oxybutynin is contraindicated

- History of narrow-angle glaucoma or urinary or gastric retention

- Current use of drugs known to effect memory and cognition

Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

Tucson, Arizona 85741-3656, United States

National City, California 91950, United States

Maitland, Florida 32751, United States

Naples, Florida 34102, United States

Ocala, Florida 34471, United States

Atlanta, Georgia 30341-4155, United States

Additional Information

Starting date: September 2008
Last updated: September 22, 2011

Page last updated: August 23, 2015

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