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

Phase 1CompletedNCT00752141

Watson Pharmaceuticals153 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

153

Conditions

Healthy Volunteers

Interventions

oxybutynin chloride immediate-releaseDRUG

capsule containing oxybutynin chloride immediate-release 5 mg tablet administered three times daily, and placebo gel administered once daily

oxybutynin chloride topical gelDRUG

oxybutynin chloride topical gel applied once daily, and capsule containing placebo tablet administered three times daily

placeboOTHER

capsule containing placebo tablet administered three times daily, and placebo gel administered once daily

Eligibility

Sex: ALLMin age: 60 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (6)

Unnamed facility

Tucson, Arizona, United States

Unnamed facility

National City, California, United States

Unnamed facility

Maitland, Florida, United States

Unnamed facility

Naples, Florida, United States

Outcomes

Primary Outcomes

Measure of accuracy of delayed recall name-phase association test

Time frame: one week

Secondary Outcomes

Effects on other cognitive domains measured by various tests

Time frame: one week

Data from ClinicalTrials.gov

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