Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers

• Sponsor: Watson Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00752141
• Collaborator: (none)
• Enrollment: 153
• Locations: 6
• Arms: 3
• Patients Per Site: 25.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: oxybutynin chloride immediate-release; Drug: oxybutynin chloride topical gel; Other: placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Official Title: Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers
• Study Start Date: Sep 1, 2008
• Actual Primary Completion Date: Oct 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 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
Experimental: 2 oxybutynin topical gel	Drug: oxybutynin chloride topical gel; oxybutynin chloride topical gel applied once daily, and capsule containing placebo tablet administered three times daily
Placebo Comparator: 3 placebo tablets plus placebo gel	Other: placebo; capsule containing placebo tablet administered three times daily, and placebo gel administered once daily

Outcome Measures

Primary Outcome Measures

1. Measure of accuracy of delayed recall name-phase association test [one week]

Secondary Outcome Measures

1. Effects on other cognitive domains measured by various tests [one week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1		Tucson	Arizona	United States	85741-3656
2		National City	California	United States	91950
3		Maitland	Florida	United States	32751
4		Naples	Florida	United States	34102
5		Ocala	Florida	United States	34471
6		Atlanta	Georgia	United States	30341-4155

Sponsors and Collaborators

• Watson Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Watson Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00752141
• Other Study ID Numbers: OTG0801
• First Posted: Sep 15, 2008
• Last Update Posted: Sep 23, 2011
• Last Verified: Sep 1, 2011

• Additional relevant MeSH terms: Mandelic Acids; Oxybutynin

Study Results

No Results Posted as of Sep 23, 2011