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

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ClinicalTrials.gov Identifier: NCT00170768
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 23, 2008
Sponsor:
Information provided by:
Novartis

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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Darifenacin Drug: Oxybutynin Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over
Study Start Date : February 2005
Actual Study Completion Date : May 2005

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)




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

Secondary Outcome Measures :
  1. Cognitive effect: measure of accuracy of delayed recall name-phase association test at week 1 & 2.
  2. Effects on other cognitive domains measured by various tests at week 1,2 and 3.


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00170768     History of Changes
Other Study ID Numbers: CDAR328A2403
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: January 23, 2008
Last Verified: January 2008

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

Additional relevant MeSH terms:
Oxybutynin
Darifenacin
Mandelic Acids
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents