Safety and Tolerability of TAR-302-5018 in Subjects With Idiopathic Overactive Bladder
- Conditions
- Idiopathic Overactive Bladder With Urinary Incontinence
- Interventions
- Drug: Trospium-Releasing Intravesical System (TAR-302-5018)
- Registration Number
- NCT03109379
- Lead Sponsor
- Taris Biomedical LLC
- Brief Summary
The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with idiopathic overactive bladder and urinary incontinence.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description TAR-302-5018 (42-day Indwelling) Trospium-Releasing Intravesical System (TAR-302-5018) Trospium-Releasing Intravesical System (TAR-302-5018) is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 42. TAR-302-5018 releases trospium gradually during the 42 day indwelling time. TAR-302-5018 (84-day Indwelling) Trospium-Releasing Intravesical System (TAR-302-5018) Trospium-Releasing Intravesical System (TAR-302-5018) is placed into the bladder through an inserter on Study Day 0 and is removed on Study Day 84. TAR-302-5018 releases trospium gradually during the 84 day indwelling time.
- Primary Outcome Measures
Name Time Method Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 1) Upon insertion, 42-day continuous exposure, and removal Safety will be assessed throughout the study based on reported AEs, investigational product events (IPEs), physical examinations (PEs), vital signs, clinical laboratory tests, scheduled cystoscopic examinations, bladder ultrasounds, bladder post-void residual volume (PVR), and the use of concomitant medications.
Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 2) Upon insertion, 84-day continuous exposure, and removal Safety will be assessed throughout the study based on reported AEs, investigational product events (IPEs), physical examinations (PEs), vital signs, clinical laboratory tests, scheduled cystoscopic examinations, bladder ultrasounds, bladder post-void residual volume (PVR), and the use of concomitant medications.
- Secondary Outcome Measures
Name Time Method Tolerability of TAR-302-5018 (Part 1) Upon insertion, 42-day continuous exposure, and removal Percent of subjects who are tolerant of TAR-302-5018 indwelling for the designated period of time and do not require TAR-302-5018 removal prior to the scheduled date of removal due to meeting any of the Subject Stopping Criteria or other drug or device constituent related adverse event.
Reduction in daily micturition episodes (Part 1) From Day 0 to Day 56 A negative change from baseline in the number of times a subject urinates into the toilet.
Tolerability of TAR-302-5018 (Part 2) Upon insertion, 84-day continuous exposure, and removal Percent of subjects who are tolerant of TAR-302-5018 indwelling for the designated period of time and do not require TAR-302-5018 removal prior to the scheduled date of removal due to meeting any of the Subject Stopping Criteria or other drug or device constituent related adverse event.
Pharmacokinetic Analysis of Plasma and Urine (Part 1) From Day 0 to Day 56 Analysis of plasma trospium exposure and urinary trospium exposure.
Reduction in incontinence over baseline (Part 2) From Day 0 to Day 112 A negative change from baseline in number of daily episodes of urinary incontinence, where incontinence is defined as an incident of involuntary loss of urine.
Pharmacokinetic Analysis of Plasma and Urine (Part 2) From Day 0 to Day 112 Analysis of plasma trospium exposure and urinary trospium exposure.
Reduction in incontinence over baseline (Part 1) From Day 0 to Day 84 A negative change from baseline in number of daily episodes of urinary incontinence, where incontinence is defined as an incident of involuntary loss of urine.
Reduction in daily micturition episodes (Part 2) From Day 0 to Day 112 A negative change from baseline in the number of times a subject urinates into the toilet.
Increase in voided volume per micturition (Part 1) From Day 0 to Day 56 An increase over baseline as measured over separate 24-hour periods.
Increase in voided volume per micturition (Part 2) From Day 0 to Day 112 An increase over baseline as measured over separate 24-hour periods.
Trial Locations
- Locations (12)
Urology of Virginia
🇺🇸Virginia Beach, Virginia, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Clinical Research Center of Florida
🇺🇸Pompano Beach, Florida, United States
DelRicht Clinical Research, LLC
🇺🇸New Orleans, Louisiana, United States
Bay State Clinical Trials, Inc
🇺🇸Watertown, Massachusetts, United States
William Beaumont Hospital - Royal Oak
🇺🇸Royal Oak, Michigan, United States
New Jersey Urology
🇺🇸Voorhees, New Jersey, United States
Michigan Institute of Urology
🇺🇸Troy, Michigan, United States
Accumed Research
🇺🇸Garden City, New York, United States
Manhattan Medical Resear
🇺🇸New York, New York, United States
UWCR - Lyndhurst Gynecologic Associates
🇺🇸Winston-Salem, North Carolina, United States
Urological Associates of Southern Arizona
🇺🇸Tucson, Arizona, United States