Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: A Double-blind, Randomized, Vehicle-controlled Phase II Study to Determine the Effects of Concomitant Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region

Study ID: NCT01083875

Conditions

Oral Mucositis

Interventions

amlexanox

Vehicle rinse

Study Description

Brief Summary: 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.

Detailed Description: