NCT01083875 - 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 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

February 29, 2000

Study Completion Date

June 30, 2001

Conditions

Oral Mucositis

Interventions

DRUG

amlexanox

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.

DRUG

Vehicle rinse

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.

Trial Locations (12)

32935

ICSL Clinical Studies, Melbourne

36607

Mobile Infirmary Medical Center, Mobile

37202

St. Thomas Hospital, Nashville

38163

University of Tennessee, Memphis

48201

Wayne State University School of Medicine, Detroit

60115

Loyola University Medical Center, Maywood

72205

University of Arkansas Medical School, Little Rock

76012

Arlington Cancer Center, Arlington

78412

Corpus Christi Cancer Center, Corpus Christi

93301

Florence Wheeler Cancer Center, Bakersfield

06030

University of Connecticut Health Center, Farmington

02215

Beth Israel Deaconess Medical Center, Boston