Overactive BladderPhase 3NCT04534491
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.
A Phase 3 study testing Oxybutynin (Oxytrol, BAY839380) in people with Overactive Bladder, run by Bayer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Oxybutynin (Oxytrol, BAY839380)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 855 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2010to 22 Jun 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stevenson Family Pharmacy
Saint Joseph, Missouri, 64504
About this study
Official title: An Oxytrol Transdermal System Actual Use Study (Consumer Trial of Oxytrol, Control)
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.
- Conditions
- Overactive Bladder
- Being tested
- Oxybutynin (Oxytrol, BAY839380)
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxybutynin (Oxytrol, BAY839380)Drug
Oxybutynin transdermal patch, 3.9 mg daily (Oxytrol Transdermal System)
| Study group | Role | What they receive |
|---|---|---|
| Oxytrol | Experimental | Subjects decided to purchase Oxytrol. Receives: Drug: Oxybutynin (Oxytrol, BAY839380) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Approximately 15 weeks from subjects' initial purchase of Oxytrol
Secondary outcomes (5)
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.
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.
Measured: Approximately 15 weeks from subjects' initial purchase of Oxytrol
The Median Time Taken to Discontinue Oxytrol Use by Verified Users Who Did Not Experience Improvement in Their Symptoms After Two Weeks of Treatment.
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.
Measured: Approximately 15 weeks from subjects' initial purchase of Oxytrol
The Percentage of Verified Users Who Did Not Stop Oxytrol Use Within Two Weeks After Experiencing no Improvement in Their Symptoms.
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.
Measured: Approximately 15 weeks from subjects' initial purchase of Oxytrol
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.
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.
Measured: Approximately 15 weeks from subjects' initial purchase of Oxytrol
The Percentage of Verified Users Who Misused the Patch (Incorrect Duration of Use or Simultaneous Use).
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.
Measured: Approximately 15 weeks from subjects' initial purchase of Oxytrol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start25 May 2010
- Primary completion22 Jun 2011
- Study completion22 Jun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 855 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534491
- Sponsor's protocol ID
- 18165
- Status last verified
- Sep 2020
- First submitted
- 27 Aug 2020
- Last updated
- 20 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Oxytrol Transdermal System Actual Use Study (Consumer Trial of Oxytrol, Control)
- ClinicalTrials.gov ID
- NCT04534491
- Acronym / sponsor ID
- 18165
- Conditions
- Overactive Bladder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 855 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 25 May 2010 (actual)
- Primary completion
- 22 Jun 2011 (actual)
- Study completion
- 22 Jun 2011 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Posted 20 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oxytrol | Experimental | Drug: Oxybutynin (Oxytrol, BAY839380)Subjects decided to purchase Oxytrol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxybutynin (Oxytrol, BAY839380)Oxybutynin transdermal patch, 3.9 mg daily (Oxytrol Transdermal System) | Drug | Oxytrol |
Primary outcome
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.
Time frame: 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.
5 secondary outcomes
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.
Time frame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
The Median Time Taken to Discontinue Oxytrol Use by Verified Users Who Did Not Experience Improvement in Their Symptoms After Two Weeks of Treatment.
Time frame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
The Percentage of Verified Users Who Did Not Stop Oxytrol Use Within Two Weeks After Experiencing no Improvement in Their Symptoms.
Time frame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
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.
Time frame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
The Percentage of Verified Users Who Misused the Patch (Incorrect Duration of Use or Simultaneous Use).
Time frame: Approximately 15 weeks from subjects' initial purchase of Oxytrol
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Oxybutynin (Oxytrol, BAY839380) in people with Overactive Bladder, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Approximately 15 weeks from subjects' initial purchase of Oxytrol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.