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

Watson Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: placebo; Drug: oxybutynin chloride topical gel; Drug: oxybutynin chloride immediate-release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00752141

OTG0801

Details and patient eligibility

About

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

Enrollment: 153 patients

Sex: All

Ages: 60 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

153 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

oral oxybutynin

Treatment:

Drug: oxybutynin chloride immediate-release

2

Experimental group

Description:

oxybutynin topical gel

Treatment:

Drug: oxybutynin chloride topical gel

3

Placebo Comparator group

Description:

placebo tablets plus placebo gel

Treatment:

Other: placebo