Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to explore the possible cognitive effects of oxybutynin tablets and oxybutynin gel.
Interventions
DRUGoxybutynin chloride immediate-release
capsule containing oxybutynin chloride immediate-release 5 mg tablet administered three times daily, and placebo gel administered once daily
DRUGoxybutynin chloride topical gel
oxybutynin chloride topical gel applied once daily, and capsule containing placebo tablet administered three times daily
OTHERplacebo
capsule containing placebo tablet administered three times daily, and placebo gel administered once daily
Sponsors
Watson Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 79 Years
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure of accuracy of delayed recall name-phase association test | one week |
Secondary
| Measure | Time frame |
|---|---|
| Effects on other cognitive domains measured by various tests | one week |
Countries
United States
Outcome results
None listed