CLINICAL TRIALS PROFILE FOR OXYTROL FOR WOMEN
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505(b)(2) Clinical Trials for Oxytrol For Women
| 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 | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Oxytrol For Women
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00224016 ↗ | Safety and Efficacy Study of Transdermal Oxybutynin to Treat Overactive Bladder With a Neurological Condition | Completed | Watson Pharmaceuticals | Phase 4 | 2004-12-01 | This study will evaluate the safety and effectiveness of an anticholinergic drug treatment administered by transdermal patch to treat overactive bladder in children who have a neurological condition (e.g. spina bifida) that contributes to their overactive bladder. |
| 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 | Unknown status | 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 |
| NCT01899794 ↗ | Efficacy of a Combined Surgical and Pharmacological Therapy to Treat Mixed Urinary Incontinence. | Completed | Centre de recherche du Centre hospitalier universitaire de Sherbrooke | Phase 4 | 2007-10-01 | The purpose of this study is to determine in female patients who suffer mixed urinary incontinence (MUI) the following: 1) the proportion of patients that are cured or improved by a single modality therapy (drug or surgery alone), cured or improved by a combined therapy (drug and surgery in any order) or non-responders to any of theses therapies; 2) which of the combined therapy sequences (surgery first, then followed by oral drug therapy or oral drug therapy first, then followed by surgery) is the most effective in patients needing combined therapy. |
| NCT01899794 ↗ | Efficacy of a Combined Surgical and Pharmacological Therapy to Treat Mixed Urinary Incontinence. | Completed | Ottawa General hospital, Ottawa University, Ottawa, Ontario, Canada | Phase 4 | 2007-10-01 | The purpose of this study is to determine in female patients who suffer mixed urinary incontinence (MUI) the following: 1) the proportion of patients that are cured or improved by a single modality therapy (drug or surgery alone), cured or improved by a combined therapy (drug and surgery in any order) or non-responders to any of theses therapies; 2) which of the combined therapy sequences (surgery first, then followed by oral drug therapy or oral drug therapy first, then followed by surgery) is the most effective in patients needing combined therapy. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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