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.

An Oxytrol Transdermal System Actual Use Study (Consumer Trial of Oxytrol, Control)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04534491

Enrollment

855

Registered

2020-09-01

Start date

2010-05-25

Completion date

2011-06-22

Last updated

2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overactive Bladder

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.

Interventions

DRUGOxybutynin (Oxytrol, BAY839380)

Oxybutynin transdermal patch, 3.9 mg daily (Oxytrol Transdermal System)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.	Approximately 15 weeks from subjects' initial purchase of Oxytrol	For each participant who was defined as a primary endpoint misuser (i.e., subjects who did not stop using Oxytrol when they either developed a new symptom referred to anywhere in the labeling, with the addition of abdominal and/or pelvic pain, or when their OAB condition worsened) the full case report form was reviewed in order to determine if there were factors that would mitigate the incorrect decision to continue use. For example, if the subject had consulted a physician and was told to continue use, such continuation is acceptable. This process is termed mitigation, because it involves determining if there are mitigating factors in the decision to continue use without posing any significant medical risk. Mitigation was conducted independently post-hoc by an external panel of advisors including two urologists and an urogynecologist and one physician employed by the sponsor.

Secondary

Measure	Time frame	Description
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.	Approximately 15 weeks from subjects' initial purchase of Oxytrol	This outcome measure did not include participants who developed abdominal and/or pelvic pain and was more reflective of how consumers stopped use according to the symptoms described on the Oxytrol labeling used in the study.
The Median Time Taken to Discontinue Oxytrol Use by Verified Users Who Did Not Experience Improvement in Their Symptoms After Two Weeks of Treatment.	Approximately 15 weeks from subjects' initial purchase of Oxytrol	This outcome measure evaluated the number of days it took for a subject to discontinue use of Oxytrol after their symptoms worsened or had stayed the same after 2 weeks of treatment. This was calculated using diary card data.
The Percentage of Verified Users Who Did Not Stop Oxytrol Use Within Two Weeks After Experiencing no Improvement in Their Symptoms.	Approximately 15 weeks from subjects' initial purchase of Oxytrol	Factors considered in this mitigation included providing: a response to one or more open ended questions that indicated a thoughtful, informed reason for continuing use; the subject talked to a physician, and the physician advised the subject that it was acceptable to continue using product; the subject had improved by Week 7 and indicated a thoughtful, informed reason for continuing use; as well as other reasons explained in the guidelines. This outcome measure was analyzed based on pre- and post-mitigation assessments but the post-mitigation analysis includes all subject data and is a better reflection of the subject's overall behavior. This was calculated by dividing the total number of subjects by the number of subjects who used the Oxytrol patch at least once.
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.	Approximately 15 weeks from subjects' initial purchase of Oxytrol	The medical risk of the newly developed symptom(s) or no sign of symptom improvement was categorized according to prospectively defined medical risk categories of 'medical risk', 'possible medical risk', and minimal/insignificant medical risk'. Mitigated data was not included in this endpoint.
The Percentage of Verified Users Who Misused the Patch (Incorrect Duration of Use or Simultaneous Use).	Approximately 15 weeks from subjects' initial purchase of Oxytrol	Factors considered in this mitigation for incorrect duration included most of the duration of patch use being correct, subject indicated understanding of the label but perhaps forgetting for a patch or two, etc. Factors considered in mitigation for simultaneous use include obvious diary errors, a subject stating that she did not do this, or a subject's doctor telling her to wear two patches at a time.

Countries

United States

Participant flow

Recruitment details

Study was conducted in US-sites and pharmacies from 25May2010 (first patient first visit) to 22Jun2011 (last patient last visit).

Pre-assignment details

Twelve hundred thirty (1230) women arrived at the pharmacies for the enrollment phase and 855 qualified participants purchased Oxytrol and entered the actual use phase.

Participants by arm

Arm	Count
Oxybutynin (Oxytrol, BAY839380) Subjects decided to purchase Oxytrol.	855
Total	855

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Non-users	70
Overall Study	Non-verifiable users	58
Overall Study	Not completed end-of-study interview	24

Baseline characteristics

Characteristic	Oxybutynin (Oxytrol, BAY839380)
Age, Continuous	58.4 Years STANDARD_DEVIATION 15
Race/Ethnicity, Customized Asian	12 Participants
Race/Ethnicity, Customized Black or African American	66 Participants
Race/Ethnicity, Customized Hispanic or Latino	64 Participants
Race/Ethnicity, Customized Other	24 Participants
Race/Ethnicity, Customized White	561 Participants
Sex: Female, Male Female	727 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	509 / 785
serious Total, serious adverse events	35 / 785

Outcome results

Primary

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.

For each participant who was defined as a primary endpoint misuser (i.e., subjects who did not stop using Oxytrol when they either developed a new symptom referred to anywhere in the labeling, with the addition of abdominal and/or pelvic pain, or when their OAB condition worsened) the full case report form was reviewed in order to determine if there were factors that would mitigate the incorrect decision to continue use. For example, if the subject had consulted a physician and was told to continue use, such continuation is acceptable. This process is termed mitigation, because it involves determining if there are mitigating factors in the decision to continue use without posing any significant medical risk. Mitigation was conducted independently post-hoc by an external panel of advisors including two urologists and an urogynecologist and one physician employed by the sponsor.