Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 Radiati

Brief 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 Summary: 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
Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Current Primary Outcome: The primary endpoint is the cumulative proportion of patients with severe mucositis (WHO mucositis score of at least 3) at a cumulative radiation dose of 5500 cGy

Original Primary Outcome:

Current Secondary Outcome: Secondary endpoints include cumulative RT to first use of an opioid for oral mucositis; cumulative RT to first ulceration; cumulative RT to first RT suspension due to oral mucositis

Original Secondary Outcome:

Information By: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Dates:
Date Received: January 9, 2003
Date Started:
Date Completion:
Last Updated: May 17, 2011
Last Verified: April 2010