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

Overview

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Study Primary Completion Date: October 2008

Interventions

• Drug: oxybutynin chloride immediate-release
  • capsule containing oxybutynin chloride immediate-release 5 mg tablet administered three times daily, and placebo gel administered once daily
• Drug: oxybutynin chloride topical gel
  • oxybutynin chloride topical gel applied once daily, and capsule containing placebo tablet administered three times daily
• Other: placebo
  • capsule containing placebo tablet administered three times daily, and placebo gel administered once daily

Arms, Groups and Cohorts

• Experimental: 1
  • oral oxybutynin
• Experimental: 2
  • oxybutynin topical gel
• Placebo Comparator: 3
  • placebo tablets plus placebo gel

Clinical Trial Outcome Measures

Primary Measures

• Measure of accuracy of delayed recall name-phase association test
  • Time Frame: one week

Secondary Measures

• Effects on other cognitive domains measured by various tests
  • Time Frame: one week

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 79 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Watson Pharmaceuticals
• Provider of Information About this Clinical Study
  • Sponsor