NCT00752141

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2008

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Last Updated

September 23, 2011

Status Verified

September 1, 2011

Enrollment Period

1 month

First QC Date

September 11, 2008

Last Update Submit

September 22, 2011

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Measure of accuracy of delayed recall name-phase association test

    one week

Secondary Outcomes (1)

  • Effects on other cognitive domains measured by various tests

    one week

Study Arms (3)

1

EXPERIMENTAL

oral oxybutynin

Drug: oxybutynin chloride immediate-release

2

EXPERIMENTAL

oxybutynin topical gel

Drug: oxybutynin chloride topical gel

3

PLACEBO COMPARATOR

placebo tablets plus placebo gel

Other: placebo

Interventions

oxybutynin chloride immediate-releaseDRUG

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

1
oxybutynin chloride topical gelDRUG

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

2
placeboOTHER

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

3

Eligibility Criteria

Age60 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Tucson, Arizona, 85741-3656, United States

Location

Unknown Facility

National City, California, 91950, United States

Location

Unknown Facility

Maitland, Florida, 32751, United States

Location

Unknown Facility

Naples, Florida, 34102, United States

Location

Unknown Facility

Ocala, Florida, 34471, United States

Location

Unknown Facility

Atlanta, Georgia, 30341-4155, United States

Location

Related Publications (1)

  • 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.

    PMID: 22909146DERIVED

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 15, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2008

Last Updated

September 23, 2011

Record last verified: 2011-09

Locations

US(6)