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Last Updated: July 28, 2021

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CLINICAL TRIALS PROFILE FOR OXYTROL

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505(b)(2) Clinical Trials for OXYTROL

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC 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 Completed Bayer Phase 3 2010-05-25 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.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for OXYTROL

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00224029 ↗ A Study Evaluating Oxybutynin in Patients With Neurogenic Overactive Bladder Associated With a Neurological Condition Completed Watson Pharmaceuticals Phase 4 2004-12-01 This study will evaluate the efficacy and safety of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in adults who have spinal cord injury.
NCT00224146 ↗ Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder Completed Watson Pharmaceuticals Phase 4 2004-05-01 This study evaluates changes in health related quality of life outcomes in patients using Oxytrol(r)
NCT01050114 ↗ OnabotulinumtoxinA (onaBoNT-A) Versus Oral Oxybutynin ER Recruiting Christopher Patrick Smith Phase 3 2013-08-01 Overactive bladder is a condition associated with symptoms of feeling the urge to urinate, urinating often, and may or may not be accompanied by leakage of urine. A patient who has a spinal cord injury (SCI) often suffers from an overactive bladder which often leads to urinary incontinence (UI - an unwanted leakage of urine). OnaBoNT-A bladder injections have been studied in clinical research trials. The results have shown an improvement in urinary symptoms by reducing how often urine leakage occurs and by increasing the amount of urine the bladder can hold. This purpose of this clinical trial is to see if onaBoNT-A is safe and effective when injected into the bladder for the treatment of UI and if it works better than a drug that is taken by mouth. A second purpose of the study is to perform research tests on the urine samples provided by the volunteers. Urine presents a rich source of information for bladder diseases and the biomarkers (the chemical make-up of the urine cells) will be examined to learn if there are yet undiscovered reasons for urinary diseases. These tests would be very beneficial because the results would lead to better treatment of the urinary diseases. Volunteers will be randomized to either: ARM 1: onaBoNT-A 200 U bladder injection and placebo oral capsule daily or ARM 2: Placebo bladder injection (saline) and oxybutynin ER 10mg capsule twice a day. The treatments are onaBoNT-A bladder injection and a placebo oral capsule once a day or placebo bladder injection and oxybutynin ER (like Ditropan) capsule twice a day. Placebo contains no active medicine. Participation in this study will be about 6-7 months and involve 5 visits to the clinic. The risks of bladder onaBoNT-A
NCT02386072 ↗ A Prospective, Observational, Multicenter Study of Patients Following Initiation of a New Course of Treatment for Overactive Bladder (OAB) Recruiting Astellas Scientific & Medical Affairs, Inc. N/A 2015-01-01 A study to identify factors that are associated with improved effectiveness in pharmacologic therapy of Overactive Bladder, from the patient perspective primarily measured by OAB-Q-SF (Overactive Bladder Questionnaire Short Form)
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 Completed Bayer Phase 3 2010-05-25 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for OXYTROL

Condition Name

Condition Name for OXYTROL
Intervention Trials
Overactive Bladder 4
Urinary Incontinence 1
Urinary Bladder Overactive 1
Urinary Bladder Diseases 1
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Condition MeSH

Condition MeSH for OXYTROL
Intervention Trials
Urinary Bladder, Overactive 4
Urologic Diseases 1
Urinary Bladder Diseases 1
Urinary Incontinence 1
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Clinical Trial Locations for OXYTROL

Trials by Country

Trials by Country for OXYTROL
Location Trials
United States 50
Canada 4
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Trials by US State

Trials by US State for OXYTROL
Location Trials
Texas 4
New York 3
Georgia 3
North Carolina 3
Missouri 2
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Clinical Trial Progress for OXYTROL

Clinical Trial Phase

Clinical Trial Phase for OXYTROL
Clinical Trial Phase Trials
Phase 4 2
Phase 3 2
N/A 1
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Clinical Trial Status

Clinical Trial Status for OXYTROL
Clinical Trial Phase Trials
Completed 3
Recruiting 2
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Clinical Trial Sponsors for OXYTROL

Sponsor Name

Sponsor Name for OXYTROL
Sponsor Trials
Watson Pharmaceuticals 2
Bayer 1
Astellas Scientific & Medical Affairs, Inc. 1
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Sponsor Type

Sponsor Type for OXYTROL
Sponsor Trials
Industry 4
Other 1
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