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Amlexanox

Patients treated with an oral rinse containing the active 0.5% amlexanox

Patients treated with an oral rinse containing no active

0.5% amlexanox oral rinse; use 5 ml every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid was be swirled around the mouth then to be swallowed. Repeated daily until completion of radiation therapy: approximately 7-8 weeks.

amlexanox

use 5 ml of the vehicle rinse every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid is be swirled around the mouth then swallowed.

Vehicle rinse

Paul Busse, M.D., Ph.D.

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.

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

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

Advanced Clinical Research Services, LLC

Access Pharmaceuticals, Inc.

David Nowotnik

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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	NCT01083875	Oral Mucositis	amlexanox Vehicle rinse	18 Years -	Access Pharmaceuticals, Inc.
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	NCT01083875	Oral Mucositis	amlexanox Vehicle rinse	18 Years -	Access Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for vehicle rinse