Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03689712 · ClinicalTrials.gov registry record · Phase 3
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
A Phase 3 study, sponsored by Galera Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 455
- Enrollment target
NCT03689712 is a Phase 3 study that has completed, run by Galera Therapeutics. The registered enrollment target is 455 participants.
The verdict
NCT03689712, a Phase 3 study, has completed, sponsored by Galera Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 455 participants
- Enrollment target
Study Summary
The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese) administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous cell carcinoma of the head and neck.
Interventions
- DRUG Placebo
- DRUG GC4419 90mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 455 participants |
| Start Date | 2018-10-03 |
| Est. Completion | 2023-08-25 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03689712
The ClinicalTrials.gov registry entry for NCT03689712 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 455 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Galera Therapeutics, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03689712 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03689712 about?
NCT03689712 is a clinical study titled "ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients". The purpose of the phase 3, clinical study is to determine if GC4419 (avasopasem manganese) administered prior to intensity-modulated radiation therapy (IMRT) reduces the severity of radiation induced oral mucositis in patients who have been diagnosed with locally advanced, non-metastatic squamous c...
What is the current status of trial NCT03689712?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 455 participants. The study started on 2018-10-03. Estimated completion is 2023-08-25.
What interventions are being tested in trial NCT03689712?
The interventions under investigation include: Placebo (DRUG), GC4419 90mg (DRUG).
Who is sponsoring clinical trial NCT03689712?
This trial is sponsored by Galera Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.