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
18 Years
N/A
Both
Stomatitis, Radiation Effects
Trial Information
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
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
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
Principal Investigator
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
CR002491
NCT ID:
NCT00051441
Start Date:
Completion Date:
February 2005
Related Keywords:
- Stomatitis
- Radiation Effects
- stomatitis
- radiation effects
- Stomatitis
- Mucositis
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