Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | PHASE2 | COMPLETED | 58 | — | — | Feb 1, 2000 | Jun 1, 2001 | Mar 18, 2010 | 12 | United States |
| Arm | Type | Description |
|---|---|---|
| 0.5% amlexanox oral rinse | EXPERIMENTAL | Patients treated with an oral rinse containing the active 0.5% amlexanox |
| Vehicle | PLACEBO_COMPARATOR | Patients treated with an oral rinse containing no active |
| Name | Type | Description |
|---|---|---|
| amlexanox | DRUG | 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. |
| Vehicle rinse | DRUG | 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. |
Inclusion Criteria: 1. Patient is 18 years of age or older; 2. Patient has a histologically documented diagnosis of cancer of the head and neck region; 3. Patient is about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over ...