StomatitisPhase 3NCT00051441
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 Phase 3 study testing Benzydamine Hydrochloride 0.15% Oral Rinse in people with Stomatitis and Radiation Effects, run by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomatitis, Radiation Effects
- What is being tested?
- Benzydamine Hydrochloride 0.15% Oral Rinse
- Type of treatment
- Pill or oral medicine
- How many people
- 605 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Feb 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
About this 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
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
Read the 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
- Being tested
- Benzydamine Hydrochloride 0.15% Oral Rinse
- Keywords
- stomatitis, radiation effects
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzydamine Hydrochloride 0.15% Oral RinseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2003 (estimated)
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Angelini
- Investigators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial, Study director, McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051441
- Sponsor's protocol ID
- CR002491
- Status last verified
- Apr 2010
- First submitted
- 9 Jan 2003
- Last updated
- 19 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00051441
- Acronym / sponsor ID
- CR002491
- Conditions
- Stomatitis, Radiation Effects
- Keywords
- stomatitis, radiation effects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Angelini
- Study completion
- Feb 2005 (actual)
- First posted
- 13 Jan 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benzydamine Hydrochloride 0.15% Oral Rinse | Drug | – |
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
1 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- 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 NasopharynxLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial study director
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Benzydamine Hydrochloride 0.15% Oral Rinse in people with Stomatitis and Radiation Effects, run by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2011.