21 and older, any sex, with Oral Mucositis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Efficacy of AG013 Compared to Placebo for Reducing OM as Measured by Duration (in Days) of Severe Oral Mucositis (WHO Grades 3 or 4)Primary· From the start of radiation therapy (RT) until 2 weeks following its completion, 7 to 9 weeks depending on the duration of CRT.
Duration (in Days) of Severe Oral Mucositis (WHO Grades 3 or 4)
US
Group
Value
95% CI
AG013
19.6
± 25.00
Placebo
20.6
± 25.20
Europe
Group
Value
95% CI
AG013
17.2
± 22.67
Placebo
15.3
± 22.54
Adverse events — posted to ClinicalTrials.gov
Time frame: From the time of screening and up to a total of 15 to 17 weeks, depending on the duration of CRT..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of the study is to evaluate the efficacy, safety and tolerability of topically administered AG013 compared to placebo for reducing Oral Mucositis (OM) in patients undergoing chemoradiation for the treatment of head and neck cancer, as measured by the duration, time to development, and overall incidence of OM during the active treatment phase, beginning from the start of chemoradiation therapy (CRT) until 2 weeks following its completion.
The effect of AG013 on patient-reported symptoms and analgesic use during the active treatment phase, and on the cumulative radiation dose administered before the onset of OM will also be evaluated, as will biomarkers and, in a subset of subjects, the PK (pharmacokinetic) profile of AG013.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07491536 — Ozone Therapy With Biomimetic Oral Care for Cancer-Related Oral Mucositis
· NA
· recruiting
NCT07400328 — Amimestrocel Injection for Preventing Severe Oral Mucositis in HSCT Patients
· Phase 2
· recruiting
NCT06525402 — Effect of Sodium Bicarbonate, Saline and Black Mulberry Syrup on Degree of Oral Mucositis in Children Receiving Chemothe
· NA
· recruiting
NCT06315855 — F.L.O.S.S. Project (Facilitated Lessons on Oral and Systemic Health in Survivors)
· NA
· recruiting
NCT05966194 — RRx-001 for Reducing Oral Mucositis in Patients Receiving Chemotherapy and Radiation for Head and Neck Cancer
· Phase 2
· recruiting
Other Oragenics, Inc. trials
Trials by the same sponsor.
NCT06870240 — A Randomised, Double-blind, Placebo-controlled Phase 2a Pilot Study to Evaluate the Safety, Tolerability, Pharmacokineti
· Phase 2
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Oragenics, Inc.
Last refreshed: 23 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03234465.