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
Completed
Advanced Clinical Research Services, LLC
Phase 2
2000-02-01
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 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
Completed
Access Pharmaceuticals, Inc.
Phase 2
2000-02-01
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.
This study involves the use of a research drug, Amlexanox, for the treatment of type 2
diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD).
Amlexanox is taken orally in a pill three times a day. The investigators plan to continue
therapy for a period of 12 weeks followed by a follow-up 4 weeks after therapy ends. The
investigators will evaluate the changes in metabolic parameters (e.g. blood cholesterol,
liver function, insulin resistance) and body composition characteristics (e.g. the pattern of
fat distribution in the body). Seven eligible subjects in this study will also be evaluated
for a change in liver disease by a liver biopsy.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
