Study to Gather Information About the Actual Use of an Adhesive Patch Placed on the Skin to Deliver Oxytrol Through the Skin Into the Bloodstream.

• Status: Completed
• Trial end date: 2011-06-22
• Target enrollment: 0
• Participant gender: Female

Summary

With this study researchers want to gather information about the consumer use behavior of Oxytrol in a simulated setting in which the medicine is sold directly to a consumer without a prescription from a healthcare professional. An area of focus was on the potential benefits of an over-the-counter status for Oxytrol and on the ongoing use behavior of the consumers. Oxytrol is a thin, flexible, clear patch that is indicated for the treatment of overactive bladder a disease characterized by a collection of symptoms, including urinary frequency, urgency, and urge incontinence. The adhesive patch is placed on the skin to deliver Oxytrol through the skin into the bloodstream.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Oxybutynin

Criteria

Inclusion criteria:

• Female

• 18 years of age or older

• Not pregnant or suspected to be pregnant

• Never trained or employed as a healthcare professional

• Neither the subject nor anyone in their household worked for a pharmaceutical company, a pharmacy, a managed care or health insurance company, a healthcare practice, or as a healthcare professional

• Had not participated in any market research study, product label study or clinical trial in the past 12 months

Exclusion criteria:

• Symptoms of blood in the urine not related to menses

• Back pain and fever in conjunction with frequency or urgency and any of the following:

dysuria, hematuria, or cloudy urine

• Narrow-angle glaucoma

• Pregnant (as determined by a urine pregnancy test among women of child bearing potential)

• Breastfeeding

• Known allergy to oxybutynin