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

September 22, 2011 updated by: Watson Pharmaceuticals
The purpose of this study is to explore the possible cognitive effects of oxybutynin tablets and oxybutynin gel.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85741-3656
    • California
      • National City, California, United States, 91950
    • Florida
      • Maitland, Florida, United States, 32751
      • Naples, Florida, United States, 34102
      • Ocala, Florida, United States, 34471
    • Georgia
      • Atlanta, Georgia, United States, 30341-4155

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
oral oxybutynin
Drug: oxybutynin chloride immediate-release
capsule containing oxybutynin chloride immediate-release 5 mg tablet administered three times daily, and placebo gel administered once daily
Experimental: 2
oxybutynin topical gel
Drug: oxybutynin chloride topical gel
oxybutynin chloride topical gel applied once daily, and capsule containing placebo tablet administered three times daily
Placebo Comparator: 3
placebo tablets plus placebo gel
Other: placebo
capsule containing placebo tablet administered three times daily, and placebo gel administered once daily

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Watson Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

September 11, 2008

First Submitted That Met QC Criteria

September 11, 2008

First Posted (Estimate)

September 15, 2008

Study Record Updates

Last Update Posted (Estimate)

September 23, 2011

Last Update Submitted That Met QC Criteria

September 22, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTG0801

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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