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NCT03168828 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of TAR-302-5018 in Subjects With Neurogenic Detrusor Overactivity Resulting From Spinal Cord Injury
A Phase 1 study of Neurogenic Detrusor Overactivity, sponsored by Taris Biomedical.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
- 4
- Study locations
NCT03168828: Completed Phase 1 study of Neurogenic Detrusor Overactivity, sponsored by Taris Biomedical.
NCT03168828 is a Phase 1 study of Neurogenic Detrusor Overactivity that has completed, run by Taris Biomedical. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03168828, a Phase 1 study of Neurogenic Detrusor Overactivity, has completed, sponsored by Taris Biomedical.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
- 4
- Study locations
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 neurogenic detrusor overactivity (NDO) resulting from spinal cord injury (SCI).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Trospium-Releasing Intravesical System (TAR-302-5018)
Study Locations (4)
Michigan
- Michigan Institute of Urology - Troy
North Carolina
- Carolinas HealthCare System - Charlotte
Virginia
- Urology of Virginia - Virginia Beach
Washington
- Virginia Mason - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2017-04-24 |
| Est. Completion | 2018-07-26 |
| Phase | Phase 1 |
What the finished NCT03168828 record still lists
NCT03168828 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Neurogenic Detrusor Overactivity appearing as the primary indexed condition, and to 1 intervention - of which Trospium-Releasing Intravesical System (TAR-302-5018) is the first listed.
NCT03168828 reports a single indexed study location in Michigan, North Carolina, Virginia.
Frequently Asked Questions
What is clinical trial NCT03168828 about?
NCT03168828 is a clinical study titled "Safety and Tolerability of TAR-302-5018 in Subjects With Neurogenic Detrusor Overactivity Resulting From Spinal Cord Injury". The purpose of this study is to determine if TAR-302-5018, an investigational drug-delivery system, is safe and tolerable in patients with neurogenic detrusor overactivity (NDO) resulting from spinal cord injury (SCI).
What is the current status of trial NCT03168828?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2017-04-24. Estimated completion is 2018-07-26.
What conditions does trial NCT03168828 study?
This clinical trial studies the following conditions: Neurogenic Detrusor Overactivity.
What interventions are being tested in trial NCT03168828?
The interventions under investigation include: Trospium-Releasing Intravesical System (TAR-302-5018) (DRUG).
Who is sponsoring clinical trial NCT03168828?
This trial is sponsored by Taris Biomedical, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03168828 being conducted?
This trial has 4 study locations across Michigan, North Carolina, Virginia, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03168828's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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