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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00170768
First received: September 9, 2005
Last updated: January 18, 2008
Last verified: January 2008
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Drug: Darifenacin
Drug: Oxybutynin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Secondary Outcome Measures:
  • 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.

Enrollment: 150
Study Start Date: February 2005
Study Completion Date: May 2005
Arms Assigned Interventions
Experimental: 1
Darifenacin
Drug: Darifenacin
Darifenacin modified release 7,5 mg tablets once daily titrated to 15 mg once daily
Other Name: Enablex
Active Comparator: 2
Oxybutynin
Drug: Oxybutynin
Oxybutynin extended release 10 mg tablet once daily titrated to 15 mg, then to 20 mg once daily
Placebo Comparator: 3
Placebo
Drug: Placebo
Placebo once daily tablet (sham titration)

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170768

Locations
United States, District of Columbia
Washington Neuropsychological Institute LLC Georgetown
Washington, District of Columbia, United States, 20016
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis East Hanover NJ
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00170768     History of Changes
Other Study ID Numbers: CDAR328A2403
Study First Received: September 9, 2005
Last Updated: January 18, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Darifenacin, oxybutynin, cognition, memory

Additional relevant MeSH terms:
Oxybutynin
Darifenacin
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 23, 2014