Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    TARIS | overactive bladder
Previous Study | Return to List | Next Study

Safety and Tolerability of TAR-302-5018 in Subjects With Idiopathic Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03109379
Recruitment Status : Active, not recruiting
First Posted : April 12, 2017
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Idiopathic Overactive Bladder With Urinary Incontinence Drug: Trospium-Releasing Intravesical System (TAR-302-5018) Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multi-center, Open-label Study of Trospium Delivered Intravesically by TAR-302-5018 to Subjects With Idiopathic Overactive Bladder (iOAB) and Urinary Incontinence
Actual Study Start Date : April 4, 2017
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAR-302-5018 (42-day Indwelling)
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.
Drug: Trospium-Releasing Intravesical System (TAR-302-5018)
TAR-302-5018 is a passive, nonresorbable trospium-releasing intravesical system whose primary mode of action is the controlled release of trospium into the bladder over a 42-day period.

Experimental: TAR-302-5018 (84-day Indwelling)
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.
Drug: Trospium-Releasing Intravesical System (TAR-302-5018)
TAR-302-5018 is a passive, nonresorbable trospium-releasing intravesical system whose primary mode of action is the controlled release of trospium into the bladder over a 42-day period.




Primary Outcome Measures :
  1. Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 1) [ Time Frame: 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.

  2. Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 2) [ Time Frame: 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 :
  1. Tolerability of TAR-302-5018 (Part 1) [ Time Frame: 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.

  2. Tolerability of TAR-302-5018 (Part 2) [ Time Frame: 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.

  3. Pharmacokinetic Analysis of Plasma and Urine (Part 1) [ Time Frame: From Day 0 to Day 56 ]
    Analysis of plasma trospium exposure and urinary trospium exposure.

  4. Pharmacokinetic Analysis of Plasma and Urine (Part 2) [ Time Frame: From Day 0 to Day 112 ]
    Analysis of plasma trospium exposure and urinary trospium exposure.

  5. Reduction in incontinence over baseline (Part 1) [ Time Frame: 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.

  6. Reduction in incontinence over baseline (Part 2) [ Time Frame: 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.

  7. Reduction in daily micturition episodes (Part 1) [ Time Frame: From Day 0 to Day 56 ]
    A negative change from baseline in the number of times a subject urinates into the toilet.

  8. Reduction in daily micturition episodes (Part 2) [ Time Frame: From Day 0 to Day 112 ]
    A negative change from baseline in the number of times a subject urinates into the toilet.

  9. Increase in voided volume per micturition (Part 1) [ Time Frame: From Day 0 to Day 56 ]
    An increase over baseline as measured over separate 24-hour periods.

  10. Increase in voided volume per micturition (Part 2) [ Time Frame: From Day 0 to Day 112 ]
    An increase over baseline as measured over separate 24-hour periods.


Other Outcome Measures:
  1. Quality of Life (Part 1) [ Time Frame: From Day 0 to Day 84 ]
    Evidence of improvement in QoL as assessed by the OAB-q Short Form.

  2. Quality of Life (Part 2) [ Time Frame: From Day 0 to Day 112 ]
    Evidence of improvement in QoL as assessed by the OAB-q Short Form.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (Part 1):

  1. Symptoms of overactive bladder (OAB) (frequency/urgency) with urge urinary incontinence or mixed urinary incontinence with a predominant urge component for at least 6 months

    • 8 or more voids per 24 hours as recorded in a diary
    • At least 4 incontinence episodes associated with urgency recorded in a 3-day diary.

      • At least 1 episode must occur per each 24 hour day
  2. Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

Exclusion Criteria (Part 1):

  1. Age <18 years.
  2. OAB caused by neurological condition.
  3. Presence of significant renal dysfunction at screening (Glomerular Filtration Rate <30 mL/min).
  4. Presence of significant polyuria of any cause at screening (urine output >4,000 mL/day).
  5. History of pelvic radiation.
  6. History of either bladder cancer or bladder pathology that the investigator deems unfit for study inclusion.
  7. Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
  8. Subjects with any bladder or urethral anatomic feature that may prevent the safe placement, indwelling use, or removal of TAR 302 5018.
  9. In the opinion of the investigator, the subject has a history of significant stress urinary incontinence.
  10. Subjects with active bladder stones or history of bladder stones <6 months prior to study entry.
  11. History of recurrent symptomatic urinary tract infections (UTIs) (>4 per 1 year).
  12. Subjects with either urinary retention or gastric retention or uncontrolled narrow-angle glaucoma.
  13. A post-void residual volume (PVR) of 300 mL or greater
  14. Subjects with known hypersensitivity to trospium, chemically-related drugs, or component excipients.
  15. Subjects with known hypersensitivity to the device materials, including silicone and nitinol.
  16. Subjects actively taking oral trospium.
  17. The addition of a new or a change in dose to a current medication for the treatment of OAB (i.e. anticholinergics, beta-3 adrenergic agonists, antispasmodics, antidepressants, or hormones) within 30 days prior to signing the informed consent form (ICF). A stable dose must continue through the final study visit. If previously used and discontinued, these medications must have been stopped for >2 weeks prior to Day 0.
  18. Intravesical onabotulinum toxin use within the last 9 months prior to the Screening Visit.
  19. Intravesical anticholinergic medications within the last 30 days prior to the Screening Visit.
  20. History of non-medication based therapy (i.e. InterStim therapy) for the treatment of OAB. History of non-invasive neuromodulation (i.e. Percutaneous Tibial Nerve Stimulation (PTNS)) is allowed if discontinued at least 8 weeks prior to Study Day 0.
  21. Female subject who is pregnant (as verified by urine test at time of screening) or lactating or of childbearing potential and not using acceptable methods of contraception.
  22. Subject has a medical condition that may cause noncompliance with the study protocol.
  23. Subject refuses to provide written informed consent.
  24. Subject will be unable or unwilling to complete the questionnaires, diaries, or attend all protocol mandated study visits.
  25. Participation in another drug, device, or behavioral study within 60 days prior to the Screening Visit.
  26. History or presence of any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, gynecological, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder that, in the opinion of the investigator, contraindicates participation.
  27. History of any of the following within 3 months prior to Screening Visit:

    • Major illness/major surgery (requiring hospitalization), including pelvic, lower back surgery or procedure unrelated to bladder cancer; most outpatient procedures are not exclusionary
    • Renal or ureteral stone disease or instrumentation
    • Childbirth
  28. Difficulty providing blood samples.
  29. Other unspecified reasons that, in the opinion of the investigator or TARIS, make the subject unsuitable for enrollment.

Inclusion Criteria (Part 2):

  1. Symptoms of idiopathic overactive bladder (iOAB) (frequency/urgency) with urge urinary incontinence or mixed urinary incontinence with a predominant urge component for at least 6 months.

    • 8 or more voids per 24 hours as recorded in a diary
    • At least 4 incontinence episodes associated with urgency recorded in a 3-day diary.

      1. At least 1 episode must occur per each 24 hour day
  2. In the opinion of the investigator, the subject has experienced an inadequate response to or limiting side effects with prior oral medications for the treatment of OAB.

Exclusion Criteria (Part 2):

  1. Age <18 years.
  2. Neurologic bladder condition.
  3. Subjects with Diabetes Mellitus (both Type 1 & Type 2) must demonstrate optimal glycemic control with HbA1c levels < 7.5 % and an absence of significant glucosuria defined as 3+ glucose via dipstick at screening.
  4. Presence of significant polyuria of any cause at screening (urine output >3,000 mL/day).
  5. Presence of nocturnal polyuria at time of study screening defined as >30% of total 24-hour urine collected from time of evening (P.M.) sleep and inclusive of the first morning (A.M.) void.
  6. History of pelvic irradiation.
  7. History of either bladder cancer or bladder pathology that the investigator deems unfit for study inclusion.
  8. Currently uses intermittent catheterization (IC) to empty the bladder within 30 days of Day 0.
  9. Subjects with any bladder or urethral anatomic feature (e.g., urethral stricture) that in the opinion of the investigator may prevent the safe placement, indwelling use, or removal of IP.
  10. Subjects with active bladder stones or history of bladder stones < 6 months prior to study entry.
  11. Gross hematuria within 30 days of Day 0.
  12. History of uncontrolled bleeding, bleeding diathesis, or underlying coagulopathy within 30 days of Day 0.
  13. In the opinion of the investigator, the subject has a history of predominance of significant stress urinary incontinence.
  14. History of > 2 symptomatic urinary tract infections in the 6-months prior to Day 0.
  15. Subjects with either urinary retention or gastric retention or uncontrolled narrow-angle glaucoma within 90 days of Day 0.
  16. A post-void residual volume (PVR) of 100-mL or greater.
  17. Subjects with known hypersensitivity to trospium, chemically-related drugs, or component excipients.
  18. Subjects with known hypersensitivity to the device materials, including silicone and nitinol.
  19. Anticholinergic or beta-3 agonist use for the treatment of urge urinary incontinence < 2 weeks prior to Day 0.
  20. History of intravesical onabotulinum toxin use within the last 9 months prior to the Screening Visit.
  21. Intravesical anticholinergic medications within the last 14 days prior to the Screening Visit.
  22. History of procedural-based neuromodulation therapy (e.g. InterStim therapy, Percutaneous Tibial Nerve Stimulation [PTNS]) for the treatment of OAB.
  23. Female subject who is pregnant (as verified by serum test at time of screening) or lactating.
  24. Subject has, in the opinion of the investigator, a medical condition that may cause noncompliance with the study protocol.
  25. Subject who is unable or unwilling to complete the questionnaires, diaries, or attend all protocol mandated study visits.
  26. Participation in another drug, device, or behavioral study within 60 days prior to the Screening Visit.
  27. History or presence of any significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, gynecological, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder, or other unspecified reasons that, in the opinion of the investigator or TARIS, make the subject unsuitable for enrollment.
  28. History of any of the following within 3 months prior to Screening Visit:

    i. Major illness/major surgery (requiring hospitalization), including pelvic, lower back surgery or procedure; most outpatient procedures are not exclusionary.

    ii. Childbirth.

  29. History of prostatic biopsy or surgery (ablative or non-ablative) within 6 months prior to Day 0.
  30. History of significant pelvic organ prolapse (Grade >/= 3).
  31. Difficulty providing blood samples.
  32. Known history of drug or alcohol dependency within 12 months of screening.
  33. Other unspecified reasons that, in the opinion of the investigator or TARIS, make the subject unsuitable for enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109379


Locations
Layout table for location information
United States, Arizona
Urological Associates of Southern Arizona
Tucson, Arizona, United States, 85715
United States, California
Medical Center for Clinical Research
San Diego, California, United States, 92108
United States, Florida
Clinical Research Center of Florida
Pompano Beach, Florida, United States, 33060
United States, Louisiana
DelRicht Clinical Research, LLC
New Orleans, Louisiana, United States, 70115
United States, Massachusetts
Bay State Clinical Trials, Inc
Watertown, Massachusetts, United States, 02472
United States, Michigan
William Beaumont Hospital - Royal Oak
Royal Oak, Michigan, United States, 48073
Michigan Institute of Urology
Troy, Michigan, United States, 48084
United States, New Jersey
New Jersey Urology
Voorhees, New Jersey, United States, 08043
United States, New York
Accumed Research
Garden City, New York, United States, 11530-1664
Manhattan Medical Resear
New York, New York, United States, 10016
United States, North Carolina
UWCR - Lyndhurst Gynecologic Associates
Winston-Salem, North Carolina, United States, 27103
United States, Virginia
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
Sponsors and Collaborators
Taris Biomedical LLC
Investigators
Layout table for investigator information
Study Director: Christopher Cutie, MD TARIS Biomedical, Inc.

Layout table for additonal information
Responsible Party: Taris Biomedical LLC
ClinicalTrials.gov Identifier: NCT03109379     History of Changes
Other Study ID Numbers: TAR-302-103
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urinary Incontinence
Enuresis
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Trospium chloride
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Urological Agents