Oral MucositisPhase 2NCT01083875
Study to Determine the Effects Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region
A Phase 2 study testing amlexanox in people with Oral Mucositis, run by Access Pharmaceuticals, Inc. at 12 sites in United States.
Trial summary
The purpose of this study was to determine the effect of 0.5% amlexanox oral rinse compared to a vehicle control on mucositis-related ulceration and erythema (objective score)and on mucositis-related oral pain (subjective score). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- amlexanox
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 12 sitesUnited States
- Study dates
- Feb 2000to Jun 2001
- Phase
- Phase 2
- 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
- Patient is 18 years of age or older;
- Patient has a histologically documented diagnosis of cancer of the head and neck region;
- Patient is about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and with planned fields to involve at least 50% of the oral mucosa;
- This criterion was amended (Amendment 01 dated August 28, 2000) to read as follows:
- 3. Amended: Patient is at a high risk of developing radiation-induced mucositis. For the purpose of this study, high-risk patients will be defined as:
- patients about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and
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- with planned fields to involve at least 40% of the oral and oropharyngeal mucosa visible by direct inspection;
- 4. Patient has a Karnofsky Performance Scale (KPS) score of 60% or more;
- 5. Patient is willing and able to cooperate with the protocol including rinsing of the oral cavity with the investigational or vehicle oral rinse 6 times per day.
- 6. The patient or guardian is capable of providing informed consent.
- 7. If female, the subject has undergone a urine pregnancy test with negative results, and has agreed to practice effective methods of contraception for the duration of the study.
Who cannot join
- Patient has had previous radiation therapy to the oral mucosa;
- Patient is about to receive hyperfractionated radiation therapy;
- Patient has active oral H. simplex lesions, oral candidiasis, or oral mucositis due to other disease processes;
- Patient has uncontrolled infection;
- Patient has HIV, Hepatitis B (HBV) (as measured by HBs-Ag) or Hepatitis C (HCV) infection;
- Patient has not recovered from oral toxicity attributable to prior treatment;
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- Patient has abnormal laboratory values that meet the following criteria:
- Serum creatinine greater than 2 x upper limit of normal
- Total bilirubin greater than 3 x upper limit of normal;
- SGOT greater than 3 x upper limit of normal;
- LDH greater than 3 x upper limit of normal;
- Patient has known sensitivities to any of the study preparation ingredients;
- Patient has participated in a clinical research study within the last 30 days prior to enrollment;
- Patient is unable to communicate or cooperate with the investigator due to language problems, poor mental development, or other reasons.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Arlington Cancer Center
Arlington, Texas, 76012
Florence Wheeler Cancer Center
Bakersfield, California, 93301
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Corpus Christi Cancer Center
Corpus Christi, Texas, 78412
Wayne State University School of Medicine
Detroit, Michigan, 48201
University of Connecticut Health Center
Farmington, Connecticut, 06030
University of Arkansas Medical School
Little Rock, Arkansas, 72205
Loyola University Medical Center
Maywood, Illinois, 60115
ICSL Clinical Studies
Melbourne, Florida, 32935
University of Tennessee
Memphis, Tennessee, 38163
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
St. Thomas Hospital
Nashville, Tennessee, 37202
About this study
Official title: A Double-blind, Randomized, Vehicle-controlled Phase II Study to Determine the Effects of Concomitant Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region
The purpose of this study was to determine the effect of 0.5% amlexanox oral rinse compared to a vehicle control on mucositis-related ulceration and erythema (objective score)and on mucositis-related oral pain (subjective score).
A secondary objective was to evaluate the safety of 0.5% amlexanox oral rinse by determining the frequency of treatment-emergent drug-related adverse events or clinical laboratory abnormalities.
- Conditions
- Oral Mucositis
- Being tested
- amlexanox, Vehicle rinse
- Keywords
- Radiation, mucositis, head and neck carcinoma, oral rinse, amlexanox, MuGard
- Medical subject headings
- Stomatitis, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amlexanoxDrug
0.5% amlexanox oral rinse; use 5 ml every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid was be swirled around the mouth then to be swallowed. Repeated daily until completion of radiation therapy: approximately 7-8 weeks.
Vehicle rinseDrug
Also called MuGard
use 5 ml of the vehicle rinse every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid is be swirled around the mouth then swallowed.
| Study group | Role | What they receive |
|---|---|---|
| 0.5% amlexanox oral rinse | Experimental | Patients treated with an oral rinse containing the active 0.5% amlexanox Receives: Drug: amlexanox |
| Vehicle | Placebo comparator | Patients treated with an oral rinse containing no active Receives: Drug: Vehicle rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of mucositis using the Oral Mucositis Assessment Score
Measured: 7 weeks
Secondary outcomes (1)
Frequency of treatment-emergent, drug-related Serious Adverse Events
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startFeb 2000
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral MucositisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Access Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Advanced Clinical Research Services, LLC
- Investigators
- Paul Busse, M.D., Ph.D., Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01083875
- Sponsor's protocol ID
- AP-C-9U01
- Status last verified
- Mar 2010
- First submitted
- 8 Mar 2010
- Last updated
- 18 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Vehicle-controlled Phase II Study to Determine the Effects of Concomitant Treatment With Amlexanox 0.5% Oral Rinse Solution on Oral Mucositis Associated With Radiation Therapy for Cancer of the Head and Neck Region
- ClinicalTrials.gov ID
- NCT01083875
- Acronym / sponsor ID
- AP-C-9U01
- Conditions
- Oral Mucositis
- Keywords
- Radiation, mucositis, head and neck carcinoma, oral rinse, amlexanox, MuGard
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Access Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Advanced Clinical Research Services, LLC
- Study start
- Feb 2000
- Study completion
- Jun 2001 (actual)
- First posted
- 10 Mar 2010 (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 was to determine the effect of 0.5% amlexanox oral rinse compared to a vehicle control on mucositis-related ulceration and erythema (objective score)and on mucositis-related oral pain (subjective score).
A secondary objective was to evaluate the safety of 0.5% amlexanox oral rinse by determining the frequency of treatment-emergent drug-related adverse events or clinical laboratory abnormalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5% amlexanox oral rinse | Experimental | Drug: amlexanoxPatients treated with an oral rinse containing the active 0.5% amlexanox |
| Vehicle | Placebo comparator | Drug: Vehicle rinsePatients treated with an oral rinse containing no active |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patient is 18 years of age or older;
- Patient has a histologically documented diagnosis of cancer of the head and neck region;
- Patient is about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and with planned fields to involve at least 50% of the oral mucosa;
- 3. Amended: Patient is at a high risk of developing radiation-induced mucositis. For the purpose of this study, high-risk patients will be defined as:
- patients about to receive a course of radiation therapy (with or without concomitant chemotherapy) with a planned dose of at least 60 Gy over 6-7 weeks, and
Key exclusion criteria (14 listed)
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 |
|---|---|---|
| amlexanox0.5% amlexanox oral rinse; use 5 ml every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid was be swirled around the mouth then to be swallowed. Repeated daily until completion of radiation therapy: approximately 7-8 weeks. | Drug | 0.5% amlexanox oral rinse |
| Vehicle rinseAlso: MuGarduse 5 ml of the vehicle rinse every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid is be swirled around the mouth then swallowed. | Drug | Vehicle |
Primary outcome
Evaluation of mucositis using the Oral Mucositis Assessment Score
Time frame: 7 weeks
1 secondary outcome
Frequency of treatment-emergent, drug-related Serious Adverse Events
Time frame: 7 weeks
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 18 Mar 2010.
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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.
Paul Busse, M.D., Ph.D. principal investigator
Beth Israel Deaconess Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing amlexanox in people with Oral Mucositis, run by Access Pharmaceuticals, Inc. at 12 sites in United States.
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 11 inclusion and 14 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 18 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Evaluation of mucositis using the Oral Mucositis Assessment Score (time frame: 7 weeks). 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 18 Mar 2010.