Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers - Full Text View

Sponsored by:	Watson Pharmaceuticals
Information provided by:	Watson Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00752141

Purpose

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

Condition	Intervention	Phase
Healthy Volunteers	Drug: oxybutynin chloride immediate-release Drug: oxybutynin chloride topical gel Other: placebo	Phase I

Drug Information available for: Chlorides Oxybutynin Oxybutynin chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers

Further study details as provided by Watson Pharmaceuticals:

Primary Outcome Measures:

Measure of accuracy of delayed recall name-phase association test [ Time Frame: one week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effects on other cognitive domains measured by various tests [ Time Frame: one week ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	September 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental oral oxybutynin	Drug: oxybutynin chloride immediate-release capsule containing oxybutynin chloride immediate-release 5 mg tablet administered three times daily, and placebo gel administered once daily
2: Experimental oxybutynin topical gel	Drug: oxybutynin chloride topical gel oxybutynin chloride topical gel applied once daily, and capsule containing placebo tablet administered three times daily
3: Placebo Comparator placebo tablets plus placebo gel	Other: placebo capsule containing placebo tablet administered three times daily, and placebo gel administered once daily

Eligibility

Ages Eligible for Study:	60 Years to 79 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752141

Locations

United States, Arizona

Tucson, Arizona, United States, 85741-3656
United States, California

National City, California, United States, 91950
United States, Florida

Maitland, Florida, United States, 32751

Ocala, Florida, United States, 34471

Naples, Florida, United States, 34102
United States, Georgia

Atlanta, Georgia, United States, 30341-4155

Sponsors and Collaborators

Watson Pharmaceuticals

More Information

Responsible Party:	Watson Laboratories ( Watson Laboratories (contact Naomi V. Dahl, Director, Clinical Affairs) )
Study ID Numbers:	OTG0801
Study First Received:	September 11, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00752141
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Oxybutynin
Healthy
Mandelic Acids

Additional relevant MeSH terms:

Parasympatholytics
Anti-Infective Agents
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Infective Agents, Urinary

Renal Agents
Cholinergic Agents
Pharmacologic Actions
Muscarinic Antagonists
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009