drugset / Trial / 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
Phase 2
Completed
58 enrolled
Access Pharmaceuticals, Inc.
Advanced Clinical Research Services, LLC · collab
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2000-02
- Primary completion
- —
- Completion
- 2001-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amlexanox | Small molecule | 0.5 % | Oral |
| Subject | Amlexanox | Small molecule | 5 ml | Oral |