Phase 3
Completed N=855
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.
Source: ClinicalTrials.gov NCT04534491 ↗Enrolled (actual)
855
Serious AEs
4.5%
Results posted
Oct 2020
Primary outcomePrimary: 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. — 14.4; 3.4 Percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
14.4; 3.4 | — |
| SECONDARY 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. |
13.1; 3.2 | — |
| SECONDARY The Median Time Taken to Discontinue Oxytrol Use by Verified Users Who Did Not Experience Improvement in Their Symptoms After Two Weeks of Treatment. |
35 | — |
| SECONDARY The Percentage of Verified Users Who Did Not Stop Oxytrol Use Within Two Weeks After Experiencing no Improvement in Their Symptoms. |
22.6; 11.0 | — |
| SECONDARY 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. |
16; 24; 284 | — |
| SECONDARY The Percentage of Verified Users Who Misused the Patch (Incorrect Duration of Use or Simultaneous Use). |
51.7; 21.2 | — |
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
Data sourced from ClinicalTrials.gov (NCT04534491). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.