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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 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.

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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

Conditions Studied

Oral Mucositis Squamous Cell Carcinoma of the Oral Cavity and Oropharynx

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

FieldValue
Enrollment Target 266 participants
Start Date 2017-12-04
Est. Completion 2021-06-24
Phase Phase 3

Sponsor

Soligenix

10 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03237325

The ClinicalTrials.gov registry entry for NCT03237325 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 266 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 81-participant average among 10 other Oral Mucositis trials with a reported enrollment target (228% higher). The listed sponsor is Soligenix, which has 10 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.