Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Oxybutynin · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Oxytrol | EXPERIMENTAL | Subjects decided to purchase Oxytrol. |
| Name | Type | Description |
|---|---|---|
| Oxybutynin (Oxytrol, BAY839380) | DRUG | Oxybutynin transdermal patch, 3.9 mg daily (Oxytrol Transdermal System) |
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...
Oxybutynin is used for overactive bladder. It is being developed by Bayer AG as a small molecule treatment for this condition. The drug is currently in Phase 3 clinical development, and it is being studied in a completed trial that enrolled 855 female participants in the United States.
Bayer AG (ticker: BAYRY) is developing Oxybutynin. The company is conducting clinical research on this small molecule for the treatment of overactive bladder. The drug is currently in Phase 3 development, with one completed clinical trial involving 855 participants.
Oxybutynin is in Phase 3 clinical development. It is an investigational small molecule being studied for overactive bladder. A Phase 3 trial has been completed, and the drug is not yet approved for use. Bayer AG is the developer of this treatment.
Oxybutynin has one completed Phase 3 clinical trial registered as NCT04534491. This study gathered information about the actual use of an adhesive patch placed on the skin to deliver Oxytrol through the skin into the bloodstream. The trial enrolled 855 female participants with overactive bladder in the United States.
Yes, Oxybutynin is the same as Oxytrol. The clinical trial NCT04534491 refers to delivering Oxytrol through the skin, indicating that Oxytrol is a brand name for Oxybutynin. This Phase 3 study was conducted in the United States with 855 female participants.