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NCT04688931 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
A Phase 3 study, sponsored by UroGen Pharma.
- Terminated
- Registry status
- Phase 3
- Development phase
- 282
- Enrollment target
NCT04688931 is a Phase 3 study that was terminated before completion, run by UroGen Pharma. The registered enrollment target is 282 participants.
The verdict
NCT04688931, a Phase 3 study, was terminated before completion, sponsored by UroGen Pharma.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 282 participants
- Enrollment target
Study Summary
This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC).
Interventions
- PROCEDURE TURBT
- DRUG UGN-102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 282 participants |
| Start Date | 2021-02-19 |
| Est. Completion | 2023-03-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04688931
The ClinicalTrials.gov registry entry for NCT04688931 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 282 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UroGen Pharma, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TURBT is the first listed.
NCT04688931 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04688931 about?
NCT04688931 is a clinical study titled "A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer". This global, randomized, controlled, open-label Phase 3 study was designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low-grad...
What is the current status of trial NCT04688931?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 282 participants. The study started on 2021-02-19. Estimated completion is 2023-03-17.
What interventions are being tested in trial NCT04688931?
The interventions under investigation include: TURBT (PROCEDURE), UGN-102 (DRUG).
Who is sponsoring clinical trial NCT04688931?
This trial is sponsored by UroGen Pharma, which has 9 total clinical trials registered on ClinicalTrials.gov.
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