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AG013: three mouth rinses/day for Mouth Sore

Phase 2
Waitlist Available
Research Sponsored by Oragenics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of radiation therapy (rt) until 2 weeks following its completion, 7 to 9 weeks depending on the duration of crt.
Awards & highlights

Summary

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.

Eligible Conditions
  • Mouth Sore

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of radiation therapy (rt) until 2 weeks following its completion, 7 to 9 weeks depending on the duration of crt.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of radiation therapy (rt) until 2 weeks following its completion, 7 to 9 weeks depending on the duration of crt. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of AG013 Compared to Placebo for Reducing OM as Measured by Duration (in Days) of Severe Oral Mucositis (WHO Grades 3 or 4)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AG013: three mouth rinses/dayExperimental Treatment1 Intervention
Subjects will rinse three times per day with AG013 mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion. The active treatment phase lasts for 7 to 9 weeks, depending on the duration of radiotherapy.
Group II: Placebo: three mouth rinses/dayPlacebo Group1 Intervention
Subjects will rinse three times per day with placebo mouth rinse beginning from the start of radiotherapy until 2 weeks following its completion. The active treatment phase lasts for 7 to 9 weeks, depending on the duration of radiotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AG013
2009
Completed Phase 1
~30

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Who is running the clinical trial?

Oragenics, Inc.Lead Sponsor
1 Previous Clinical Trials
48 Total Patients Enrolled
Alan Joslyn, Ph.D.Study DirectorSponsor GmbH
~25 spots leftby Jul 2025
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