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OpenTrials
Completed

NCT Number: NCT00752141

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

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

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Key information

Conditions

Healthy Volunteers

Age range

60 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxybutynin chloride immediate-release

Drug

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

oxybutynin chloride topical gel

Drug

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

Placebo

Other

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

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

Sponsors and collaborators

Lead sponsor

Watson Pharmaceuticals

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
First posted
Sep 15, 2008
Registry last updated
Sep 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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