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

NCT ID: NCT00752141

Last Updated: 2011-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

153 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

oral oxybutynin

Group Type EXPERIMENTAL

oxybutynin chloride immediate-release

Intervention Type DRUG

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

2

oxybutynin topical gel

Group Type EXPERIMENTAL

oxybutynin chloride topical gel

Intervention Type DRUG

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

3

placebo tablets plus placebo gel

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

Interventions

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oxybutynin chloride immediate-release

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

Intervention Type DRUG

oxybutynin chloride topical gel

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

Intervention Type DRUG

placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Watson Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tucson, Arizona, United States

Site Status

National City, California, United States

Site Status

Maitland, Florida, United States

Site Status

Naples, Florida, United States

Site Status

Ocala, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 22909146 (View on PubMed)

Other Identifiers

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OTG0801

Identifier Type: -

Identifier Source: org_study_id