NCT00170768

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 healthy-volunteers

Timeline
Completed

Started Feb 2005

Shorter than P25 for phase_2 healthy-volunteers

Geographic Reach
1 country

1 active site

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

February 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

January 23, 2008

Status Verified

January 1, 2008

First QC Date

September 9, 2005

Last Update Submit

January 18, 2008

Conditions

Healthy Volunteers

Keywords

Darifenacin, oxybutynin, cognition, memory

Outcome Measures

Primary Outcomes (1)

  • Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.

Secondary Outcomes (2)

  • Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 1 & 2.

  • Effects on other cognitive domains measured by various tests at week 1,2 and 3.

Study Arms (3)

1

EXPERIMENTAL

Darifenacin

Drug: Darifenacin

2

ACTIVE COMPARATOR

Oxybutynin

Drug: Oxybutynin

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

DarifenacinDRUG

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

Also known as: Enablex
1
OxybutyninDRUG

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

2
PlaceboDRUG

Placebo once daily tablet (sham titration)

3

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Neuropsychological Institute LLC Georgetown

Washington D.C., District of Columbia, 20016, United States

Location

MeSH Terms

Interventions

darifenacinoxybutynin

Study Officials

  • Novartis

    East Hanover NJ

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

February 1, 2005

Study Completion

May 1, 2005

Last Updated

January 23, 2008

Record last verified: 2008-01

Locations

US(1)