NCT00051441

Safety & Efficacy Study of Benzydamine Oral Rinse for the Treatment of Oral Mucositis (Mouth Sores) Resulting From Radiation Therapy for Cancer of the Oral Cavity, Oropharynx, or Nasopharynx

A Double-Blind, Randomized, Vehicle-Controlled Study Comparing the Safety and Efficacy of Benzydamine HCl 0.15% Oral Rinse Including a Separate Open-Label Standard of Care Arm in Subjects With Radiation-Induced Mucositis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 605 (actual)
• Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the effectiveness and safety of benzydamine hydrochloride 0.15% oral rinse to a vehicle oral rinse in the treatment of radiation-induced oral mucositis, and to compare the care normally used for radiation-induced oral mucositis to vehicle oral rinse to ensure that the vehicle does not have detrimental effects on the oral mucosa

Detailed description

This is a multicenter, double-blind, randomized, vehicle-controlled study including an open-label standard of care arm, to determine the effectiveness and safety of benezydamine hydrochloride 0.15% oral rinse as compared with vehicle oral rinse, and vehicle oral rinse as compared to the care normally used in the treatment of radiation-induced oral mucositis. The hypotheses are that benzydamine hydrochloride 0.15% oral rinse is better than vehicle oral rinse as measured by the proportion of patients reaching a WHO mucositis score of 3 by 5500 cGy and vehicle is no worse than the standard of care as measured by the proportion of patients reaching a WHO mucositis score of 3 by 5500 cGy. Patients receiving benzydamine hydrochloride 0.15% or vehicle double-blind oral rinses will place 15 mL in the mouth for 2 minutes, gargling for a few seconds at the beginning and end of the rinse, and then expectorate the entire dose. Dosing with oral rinses will be every 2 - 3 hours while awake for a minimum of 4 times daily to a maximum of 8 times per day. Double-blind oral rinses will continue daily throughout the duration of the subjects radiation treatment regimen plus 2 additional weeks

Conditions

• Stomatitis
• Radiation Effects

Interventions

Type	Name	Description
DRUG	Benzydamine Hydrochloride 0.15% Oral Rinse

Timeline

• Completion: 2005-02-01
• First posted: 2003-01-13
• Last updated: 2011-05-19