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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: oxybutynin chloride immediate-release; Drug: oxybutynin chloride topical gel; Other: placebo

• Registration Number: NCT00752141
• Lead Sponsor: Watson Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-11
• Study First Submitted QC: 2008-09-11
• Study First Posted: 2008-09-15
• Primary Completion: 2008-10
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-22
• Last Update Posted: 2011-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	oxybutynin chloride immediate-release	oral oxybutynin
2	oxybutynin chloride topical gel	oxybutynin topical gel
3	placebo	placebo tablets plus placebo gel

Primary Outcome Measures

Name	Time	Method
Measure of accuracy of delayed recall name-phase association test	one week

Secondary Outcome Measures

Name	Time	Method
Effects on other cognitive domains measured by various tests	one week