NCT01400620

Safety and Efficacy of IZN-6N4 Oral Rinse for the Prevention of Oral Mucositis in Patients With Head and Neck Cancer

Phase 2 Study to Evaluate the Safety and Efficacy of IZN-6N4 for the Prevention of Chemo-Radiation-Induced Oral Mucositis in Patients With Head and Neck Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Izun Pharma Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether an oral rinse composed of botanical extracts is effective in the prevention of severe inflammation of the lining of the oral cavity caused by chemotherapy and radiation therapy for head and neck cancer.

Conditions

• Oral Mucositis

Interventions

Type	Name	Description
DRUG	IZN-6N4	Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks

Timeline

• Start date: 2012-03-01
• Primary completion: 2017-01-01
• Completion: 2017-01-01
• First posted: 2011-07-22
• Last updated: 2018-03-13

Locations

10 sites across 2 countries: United States, Israel