NCT02324335

Study of the Effects of Brilacidin Oral Rinse on Radiation-induced Oral Mucositis in Patients With Head and Neck Cancer

Phase 2 Study to Evaluate the Efficacy & Safety of Brilacidin Oral Rinse Administered Daily for 7 Weeks in Attenuating Oral Mucositis in Patients With Head & Neck Cancer Receiving Chemoradiation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Innovation Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Oral Mucositis (OM) is a painful and debilitating side effect of many of the drug/radiation regimens used to treat cancer. This study examines the investigational drug brilacidin and its possible application in prevention of oral mucositis in patients undergoing chemoradiation for treatment of head and neck cancer.

Detailed description

This study will examine whether daily oral rinses with a solution containing brilacidin will prevent the occurrences of OM or lessen the severity of OM if it occurs. Patients will use an oral rinse 3 times daily for up to seven weeks during chemoradiation for head and neck cancer.

Conditions

• Head and Neck Neoplasms
• Mucositis

Interventions

Type	Name	Description
DRUG	Brilacidin	Oral Rinse used 3 times daily for 7 weeks
OTHER	Placebo

Timeline

• Start date: 2014-08-14
• Primary completion: 2017-10-25
• Completion: 2017-11-22
• First posted: 2014-12-24
• Last updated: 2019-01-16
• Results posted: 2019-01-16

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study