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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

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Purpose
Eligibility
Location and Contact Information
More Information

This study is currently recruiting patients.

Sponsored by:	McNeil Consumer & Specialty Pharmaceuticals
Information provided by:	McNeil Consumer & Specialty Pharmaceuticals

Purpose

This study will test the effectiveness and safety of an investigational medication for mucositis (mouth sores/ulcers). Researchers are looking into whether the medication being studied will reduce the risk and duration of severe mucositis, as well as the interruptions in cancer treatment, that the condition sometimes causes.

Currently, there is no FDA approved medication available to prevent the mouth sores or help them heal faster. To lessen the pain, people often rely on pain medications, mouth rinses, and a change in diet to less irritating foods and plenty of liquids.

This study is called the ARISE study (Addressing Radiation Induced Side Effects).

Condition	Treatment or Intervention	Phase
Mouth Neoplasms	Drug: Benzydamine Hydrochloride Oral Rinse	Phase III

MedlinePlus related topics: Oral Cancer

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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 Radiation-Induced Mucositis.

Further Study Details:

Expected Total Enrollment: 750

Study start: December 2002

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

Criteria

A diagnosis of pathologically confirmed head and neck cancer of the oral cavity, oropharynx or nasopharynx.
Scheduled to receive a continuous course (e.g. 6-8 wks) of conventional or hyperfractionated external beam radiation with or without chemotherapy.
At least 2 oral tissue sites (not including areas of previous lesion, tumor, surgical resection or the lips) must be included in the RT treatment volume and planned to receive a total radiation dose of 5500 cGy or higher.

Location and Contact Information

Pauline Calkins, B.S. 215-273-7111 pcalkin@mccus.jnj.com

Alabama
University of Alabama, Birmingham, Alabama, 35249-6832, United States; Recruiting

Roger Ove, MD, Principal Investigator

Mobile Infirmary Medical Center, Mobile, Alabama, 36607, United States; Recruiting

John Russell, MD, Principal Investigator

Discovery Alliance, Inc. Mobile Infirmary Medical Center, Mobile, Alabama, 36607, United States; Recruiting

John Russell, MD, Principal Investigator

Southeast Alabama Medical Center, Dothan, Alabama, 36301, United States; Recruiting

Steven H Stokes, MD, Principal Investigator

Arizona
Foundation for Cancer Research and Education, Phoenix, Arizona, 85013, United States; Recruiting