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NCT03237325 · ClinicalTrials.gov registry record · Phase 3
DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer
A Phase 3 study of Oral Mucositis and Squamous Cell Carcinoma of the Oral Cavity and Oropharynx, sponsored by Soligenix.
- Completed
- Registry status
- Phase 3
- Development phase
- 266
- Enrollment target
- 20
- Study locations
NCT03237325: Completed Phase 3 study of Oral Mucositis and Squamous Cell Carcinoma of the Oral Cavity and Oropharynx, sponsored by Soligenix.
NCT03237325 is a Phase 3 study of Oral Mucositis and Squamous Cell Carcinoma of the Oral Cavity and Oropharynx that has completed, run by Soligenix. The registered enrollment target is 266 participants, above the 81-participant average among 10 other Oral Mucositis trials with a reported enrollment target (228% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03237325, a Phase 3 study of Oral Mucositis and Squamous Cell Carcinoma of the Oral Cavity and Oropharynx, has completed, sponsored by Soligenix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 266 participants
- Enrollment target
- 20
- Study locations
Study Summary
To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer
Primary Outcome
To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis (SOM; defined as World Health Organization \[WHO\] Grade ≥3). Duration of SOM is defined as the number of days from the onset of SOM until resolution of SOM. OM is evaluated using the published WHO OM grading scale that uses a scale of 0 to 4, with SOM defined as a score ≥3.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SGX942
Study Locations (20)
Georgia
- University Cancer & Blood - Athens
- Augusta University - Augusta
- Memorial Health - Savannah
California
- Loma Linda University Health - Loma Linda
- Pomona Valley Hospital Medical Center - Pomona
Florida
- Cancer Specialists of North Florida - Jacksonville
- Lakes Research - Miami Lakes
Illinois
- University of Illinois Cancer Center - Chicago
- Carle Cancer Center - Urbana
Iowa
- Des Moines Oncology Research Association - Des Moines
- University of Iowa Hospitals and Clinics - Iowa City
Arizona
- Arizona Clinical Research Center - Tucson
Kentucky
- Ashland Bellefonte Cancer Center - Ashland
Louisiana
- Willis Knighton Cancer Center - Shreveport
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2021-06-24 |
| Phase | Phase 3 |
What the finished NCT03237325 record still lists
NCT03237325 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, above the 81-participant average among 10 other Oral Mucositis trials with a reported enrollment target (228% higher).
The record links to 2 conditions, with Oral Mucositis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03237325 names 20 study sites across 14 states, led by Georgia, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03237325 about?
NCT03237325 is a clinical study titled "DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer". To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer
What is the current status of trial NCT03237325?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 266 participants. The study started on 2017-12-04. Estimated completion is 2021-06-24.
What conditions does trial NCT03237325 study?
This clinical trial studies the following conditions: Oral Mucositis, Squamous Cell Carcinoma of the Oral Cavity and Oropharynx.
What interventions are being tested in trial NCT03237325?
The interventions under investigation include: Placebo (DRUG), SGX942 (DRUG).
Who is sponsoring clinical trial NCT03237325?
This trial is sponsored by Soligenix, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03237325 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Oral Mucositis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03237325's enrollment target sits among peer trials
266 1st of 10 higher than 10 of 10 other Oral Mucositis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Oral Mucositis 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
-
Intraoral Photobiomodulation Therapy to Prevent Oral Mucositis in Patients Undergoing Hematopoietic Cell Transplantation
RECRUITING · NA
-
Coconut Oil to Prevent Mouth Sores in Pediatric Patients Receiving High Dose Chemotherapy
RECRUITING · Phase 2
-
RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
RECRUITING · Phase 2
-
F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors)
RECRUITING · NA
-
Photobiomodulation for the Prevention of Oral Mucositis
ACTIVE NOT RECRUITING · Phase 2
-
MIT-001 for Prevention of CCRT-Induced OM in HNSCC Patients
ACTIVE NOT RECRUITING · Phase 2
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