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

NCT03109379 | Completed Phase 1 FDA Drug

• 1 other identifier: TAR-302-103
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 12

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.

Conditions

Idiopathic Overactive Bladder With Urinary Incontinence

Outcome Measures

Primary Outcomes (2)

• Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 1)

  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.

  Upon insertion, 42-day continuous exposure, and removal

• Safety of TAR-302-5018 assessed throughout the study based on reported AEs (Part 2)

  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.

  Upon insertion, 84-day continuous exposure, and removal

Secondary Outcomes (10)

• Tolerability of TAR-302-5018 (Part 1)

  Upon insertion, 42-day continuous exposure, and removal

• Tolerability of TAR-302-5018 (Part 2)

  Upon insertion, 84-day continuous exposure, and removal

• Pharmacokinetic Analysis of Plasma and Urine (Part 1)

  From Day 0 to Day 56

• Pharmacokinetic Analysis of Plasma and Urine (Part 2)

  From Day 0 to Day 112

• Reduction in incontinence over baseline (Part 1)

  From Day 0 to Day 84

Other Outcomes (2)

• Quality of Life (Part 1)

  From Day 0 to Day 84

• Quality of Life (Part 2)

  From Day 0 to Day 112

Study Arms (2)

TAR-302-5018 (42-day Indwelling)

EXPERIMENTAL

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 (84-day Indwelling)

EXPERIMENTAL

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)

Interventions

Trospium-Releasing Intravesical System (TAR-302-5018) DRUG

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.

TAR-302-5018 (42-day Indwelling); TAR-302-5018 (84-day Indwelling)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Inadequate response or limiting side effects with anticholinergics for the treatment of OAB

You may not qualify if:

• Age \<18 years.
• OAB caused by neurological condition.
• Presence of significant renal dysfunction at screening (Glomerular Filtration Rate \<30 mL/min).
• Presence of significant polyuria of any cause at screening (urine output \>4,000 mL/day).
• History of pelvic radiation.
• Active malignancies within 12 months with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
• Subjects with any bladder or urethral anatomic feature that may prevent the safe placement, indwelling use, or removal of TAR 302 5018.
• In the opinion of the investigator, the subject has a history of significant stress urinary incontinence.
• Subjects with active bladder stones or history of bladder stones \<6 months prior to study entry.
• History of recurrent symptomatic urinary tract infections (UTIs) (\>4 per 1 year).
• Subjects with either urinary retention or gastric retention or uncontrolled narrow-angle glaucoma.
• A post-void residual volume (PVR) of 300 mL or greater
• Subjects with known hypersensitivity to trospium, chemically-related drugs, or component excipients.
• Subjects with known hypersensitivity to the device materials, including silicone and nitinol.
• Subjects actively taking oral trospium.

Sponsors & Collaborators

• Taris Biomedical LLC: lead

Study Sites (12)

Urological Associates of Southern Arizona

Tucson, Arizona, 85715, United States

Location

Medical Center for Clinical Research

San Diego, California, 92108, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

DelRicht Clinical Research, LLC

New Orleans, Louisiana, 70115, United States

Location

Bay State Clinical Trials, Inc

Watertown, Massachusetts, 02472, United States

Location

William Beaumont Hospital - Royal Oak

Royal Oak, Michigan, 48073, United States

Location

Michigan Institute of Urology

Troy, Michigan, 48084, United States

Location

New Jersey Urology

Voorhees Township, New Jersey, 08043, United States

Location

Accumed Research

Garden City, New York, 11530-1664, United States

Location

Manhattan Medical Resear

New York, New York, 10016, United States

Location

UWCR - Lyndhurst Gynecologic Associates

Winston-Salem, North Carolina, 27103, United States

Location

Urology of Virginia

Virginia Beach, Virginia, 23462, United States

Location

Study Officials

• Christopher Cutie, MD

  TARIS Biomedical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 12, 2017
• Study Start: April 4, 2017
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: January 13, 2020

Record last verified: 2020-01

Locations

US (12)