Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over

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

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2005-05-31

Brief Summary

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The purpose of this study is to explore the possible cognitive effects of darifenacin modified release and long-acting oxybutynin.

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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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Darifenacin

Group Type EXPERIMENTAL

Darifenacin

Intervention Type DRUG

Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily

2

Oxybutynin

Group Type ACTIVE_COMPARATOR

Oxybutynin

Intervention Type DRUG

Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once daily tablet (sham titration)

Interventions

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Darifenacin

Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily

Intervention Type DRUG

Oxybutynin

Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily

Intervention Type DRUG

Placebo

Placebo once daily tablet (sham titration)

Intervention Type DRUG

Other Intervention Names

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Eligibility Criteria

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Inclusion Criteria

* Males and females aged 60 and over
* United States 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 anti-cholinergic drugs is contraindicated, including the use of drugs with anti-cholinergic effects
* Volunteers with history of urinary retention or current bladder outlet obstruction, as determined by the investigator

Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No