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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

Primary Purpose

Stomatitis, Radiation Effects

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Benzydamine Hydrochloride 0.15% Oral Rinse
Sponsored by
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomatitis focused on measuring stomatitis, radiation effects

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Karnofsky performance scale >= 60% Diagnosis of pathologically confirmed malignancy involving one or more of the following sites: oral cavity, oropharynx extending down to the level of the supraglottic area, nasopharynx, maxillary sinus and parotid gland high risk for developing oral and/or oropharyngeal mucositis due to radiation to head and neck areas scheduled to receive a continuous course (eg, often six to eight weeks) of conventional or hyperfractionated external beam radiation for cancer of the head and neck region (subjects who had surgery prior to radiation are eligible) with or without concomitant chemotherapy at least two oral tissue sites (not including areas of previous lesions, 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, given in a single daily fraction of 180 to 220 cGy or twice daily fractions of 110 to 150 cGy Exclusion Criteria: Known hypersensitivity to benzydamine HCl and/or any of the other components including alcohol, menthol, glycerin, flavoring agents, and preservatives oral or oropharyngeal mucositis present at the time of entry into the study treatment regimen consisting of noncontinuous radiation therapy received chemotherapy within 21 days of entry into the study as defined by initiation of radiation scheduled to receive or have received brachytherapy chronically being medicated for conditions other than tumor-related pain with oral and/or parenteral prescription steroids or analgesics use of chlorhexidine gluconate (Peridex), amifostine (Ethyol), topical antibiotics to the mouth (ie, tetracycline), topical steroids to the mouth, povidone iodine rinses, glutamine oral rinses, selective decontamination, and Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) use of mouthwash containing other exclusionary medications and any other medication(s) without an approved indication for topical oral use with the exception of liquid antacid formulations (eg, Maalox, Mylanta) participated in an investigational study within 30 days prior to enrolling into the study where an experimental drug and/or product was taken not willing and/or able to take opioids for any reason cryotherapy (ie, ice chips or popsicles) prior to or during chemotherapy infusion

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    January 9, 2003
    Last Updated
    May 17, 2011
    Sponsor
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
    Collaborators
    Angelini
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00051441
    Brief Title
    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
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
    Collaborators
    Angelini

    4. Oversight

    5. Study Description

    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 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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stomatitis, Radiation Effects
    Keywords
    stomatitis, radiation effects

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    605 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Benzydamine Hydrochloride 0.15% Oral Rinse
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Karnofsky performance scale >= 60% Diagnosis of pathologically confirmed malignancy involving one or more of the following sites: oral cavity, oropharynx extending down to the level of the supraglottic area, nasopharynx, maxillary sinus and parotid gland high risk for developing oral and/or oropharyngeal mucositis due to radiation to head and neck areas scheduled to receive a continuous course (eg, often six to eight weeks) of conventional or hyperfractionated external beam radiation for cancer of the head and neck region (subjects who had surgery prior to radiation are eligible) with or without concomitant chemotherapy at least two oral tissue sites (not including areas of previous lesions, 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, given in a single daily fraction of 180 to 220 cGy or twice daily fractions of 110 to 150 cGy Exclusion Criteria: Known hypersensitivity to benzydamine HCl and/or any of the other components including alcohol, menthol, glycerin, flavoring agents, and preservatives oral or oropharyngeal mucositis present at the time of entry into the study treatment regimen consisting of noncontinuous radiation therapy received chemotherapy within 21 days of entry into the study as defined by initiation of radiation scheduled to receive or have received brachytherapy chronically being medicated for conditions other than tumor-related pain with oral and/or parenteral prescription steroids or analgesics use of chlorhexidine gluconate (Peridex), amifostine (Ethyol), topical antibiotics to the mouth (ie, tetracycline), topical steroids to the mouth, povidone iodine rinses, glutamine oral rinses, selective decontamination, and Granulocyte Macrophage-Colony Stimulating Factor (GM-CSF) use of mouthwash containing other exclusionary medications and any other medication(s) without an approved indication for topical oral use with the exception of liquid antacid formulations (eg, Maalox, Mylanta) participated in an investigational study within 30 days prior to enrolling into the study where an experimental drug and/or product was taken not willing and/or able to take opioids for any reason cryotherapy (ie, ice chips or popsicles) prior to or during chemotherapy infusion
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial
    Organizational Affiliation
    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=904&filename=CR002491_CSR.pdf
    Description
    Safety and 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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