Overview

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

Status:
Completed

Trial end date:
2001-06-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Access Pharmaceuticals, Inc.

Collaborator:

Advanced Clinical Research Services, LLC

Treatments:

Amlexanox