Cognitive Effects of Darifenacin and Oxybutynin Extended... | NCT00170768

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

NCT00170768

Sponsor

Novartis

Status

Completed

Last Update Posted

Jan 23, 2008Estimated

Enrollment

150Actual

Phase

Phase 2

Conditions

Healthy Volunteers

Interventions

Darifenacin
Oxybutynin
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Feb 2005

Primary Completion Date

Not provided

Completion Date

May 2005Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2008

Last Update Posted Date

Jan 23, 2008Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Darifenacin	Drug: Darifenacin
2	Active Comparator	Oxybutynin	Drug: Oxybutynin
3	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Darifenacin	Drug	Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 3.

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Other protocol defined inclusion/exclusion criteria may apply.

- Current use of drugs known to effect memory and cognition Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis	East Hanover NJ	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Washington Neuropsychological Institute LLC Georgetown		Washington D.C.	District of Columbia	20016	United States

Intervention Browse Module

MeSH Terms

ID	Term
C101207	darifenacin
C005419	oxybutynin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided