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CompletedNCT00752141Updated Sep 23, 2011

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

A Phase 1 interventional study of oxybutynin chloride immediate-release and oxybutynin chloride topical gel in Healthy Volunteers, sponsored by Watson Pharmaceuticals. Completed at 6 sites in United States. Open to participants aged 60 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-23.

Sponsored by Watson Pharmaceuticals · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
153
Allocation
Randomized
Ages
60 Years to 79 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Watson Pharmaceuticals is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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

05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
153 participants (actual)

Study arms

  • Experimental
    1

    oral oxybutynin

    Drug: oxybutynin chloride immediate-release

  • Experimental
    2

    oxybutynin topical gel

    Drug: oxybutynin chloride topical gel

  • Placebo comparator
    3

    placebo tablets plus placebo gel

    Other: placebo

Interventions

  • Drugoxybutynin chloride immediate-release

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

  • Drugoxybutynin chloride topical gel

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

  • Otherplacebo

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

06

What researchers measure

Primary outcomes

  1. Measure of accuracy of delayed recall name-phase association test

    Time frame: one week

Secondary outcomes

  1. Effects on other cognitive domains measured by various tests

    Time frame: one week

07

Study locations

6 sites
  • 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
08

References and documents

Publications

  • Kay GG, Staskin DR, MacDiarmid S, McIlwain M, Dahl NV. Cognitive effects of oxybutynin chloride topical gel in older healthy subjects: a 1-week, randomized, double-blind, placebo- and active-controlled study. Clin Drug Investig. 2012 Oct 1;32(10):707-14. doi: 10.1007/BF03261924. PubMed 22909146 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00752141
Lead sponsor
Watson Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 15, 2008
Start date
Sep 2008
Primary completion
Oct 2008
Last update
Sep 23, 2011
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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