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Clinical trialNCT01083875CompletedPhase 2Interventional

Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region

SponsorAccess Pharmaceuticals, Inc.Enrollment58Oral Mucositis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

The purpose of this study was to determine the effect of 0.5% amlexanox oral rinse compared to a vehicle control on mucositis-related ulceration and erythema (objective score)and on mucositis-related oral pain (subjective score). A secondary objective was to evaluate the safety of 0.5% amlexanox oral rinse by determining the frequency of treatment-emergent drug-related adverse events or clinical laboratory abnormalities.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Mobile Infirmary Medical Center

    Mobile, Alabama, United States

  • University of Arkansas Medical School

    Little Rock, Arkansas, United States

  • Florence Wheeler Cancer Center

    Bakersfield, California, United States

  • University of Connecticut Health Center

    Farmington, Connecticut, United States

  • Icsl Clinical Studies

    Melbourne, Florida, United States

  • Loyola University Medical Center

    Maywood, Illinois, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, United States

  • Wayne State University School of Medicine

    Detroit, Michigan, United States

  • University of Tennessee

    Memphis, Tennessee, United States

  • St. Thomas Hospital

    Nashville, Tennessee, United States

  • Arlington Cancer Center

    Arlington, Texas, United States

  • Corpus Christi Cancer Center

    Corpus Christi, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Vehicle rinseAmlexanox
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
29 Feb 2000
Primary completion
—
Completion
30 Jun 2001
Last update posted
18 Mar 2010
Registered enrollment
58
Registry id
NCT01083875
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.