Clinical trial NCT04534491: 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.
Official title: An Oxytrol Transdermal System Actual Use Study (Consumer Trial of Oxytrol, Control)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-09-01
Enrollment: 855
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: The Percentage of Participants Who Did Not Stop Use When They Either Developed a New Symptom Referred to Anywhere in the Labeling or When Their Condition Worsened Including Abdominal and/or Pelvic Pain.
timeFrame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
Secondary outcomes:
measure: The Percentage of Verified Users Who Did Not Stop Use When Their Condition Worsened or They Developed a New Symptom Referred to in the Labeling.
timeFrame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
measure: The Median Time Taken to Discontinue Oxytrol Use by Verified Users Who Did Not Experience Improvement in Their Symptoms After Two Weeks of Treatment.
timeFrame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
measure: The Percentage of Verified Users Who Did Not Stop Oxytrol Use Within Two Weeks After Experiencing no Improvement in Their Symptoms.
timeFrame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
measure: Number of Participants With Medical Risk Associated With the Development of New Symptoms or When Symptoms Did Not Improve for Patients That Continued Oxytrol Treatment.
timeFrame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
measure: The Percentage of Verified Users Who Misused the Patch (Incorrect Duration of Use or Simultaneous Use).
timeFrame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
Other outcomes:
Locations:
city: Saint Joseph
country: United States
facility: Stevenson Family Pharmacy
state: Missouri
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: