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

NCT03109379 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2020-01-13

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Taris Biomedical LLC

    lead INDUSTRY

Principal Investigators

  • Christopher Cutie, MD · TARIS Biomedical, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-04
Primary Completion
2019-09-27
Completion
2019-09-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03109379 on ClinicalTrials.gov