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Last Updated: April 27, 2024

CLINICAL TRIALS PROFILE FOR AMLEXANOX


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All Clinical Trials for amlexanox

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01083875 ↗ 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.
NCT01083875 ↗ 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.
NCT01842282 ↗ Amlexanox for Type 2 Diabetes and Obesity Suspended University of Michigan Phase 2 2013-07-19 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.
NCT01975935 ↗ Efficacy of Amlexanox vs. Placebo in Type 2 Diabetic Patients Completed University of Michigan Phase 2 2014-01-01 This study involves research about an investigational medicine called Amlexanox. The reason for this study is to find out how Amlexanox can improve type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). In this study, Amlexanox is considered to be investigational (not approved by the Food and Drug Administration [FDA]) for type 2 diabetes, insulin resistance, obesity and non-alcoholic fatty liver disease (NAFLD). This is a placebo controlled study. There is a 50-50 chance that the patient may either receive the study drug, Amlexanox, or a placebo (sugar pill). Neither the patient or the study doctors will know if the patient is receiving the study drug or placebo.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for amlexanox

Condition Name

Condition Name for amlexanox
Intervention Trials
Obesity 2
Diabetes Mellitus Type 2 2
Non Alcoholic Fatty Liver Disease 1
Non-alcoholic Fatty Liver Disease 1
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Condition MeSH

Condition MeSH for amlexanox
Intervention Trials
Non-alcoholic Fatty Liver Disease 2
Liver Diseases 2
Fatty Liver 2
Diabetes Mellitus, Type 2 2
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Clinical Trial Locations for amlexanox

Trials by Country

Trials by Country for amlexanox
Location Trials
United States 12
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Trials by US State

Trials by US State for amlexanox
Location Trials
Michigan 3
Texas 1
Tennessee 1
Massachusetts 1
Illinois 1
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Clinical Trial Progress for amlexanox

Clinical Trial Phase

Clinical Trial Phase for amlexanox
Clinical Trial Phase Trials
Phase 2 3
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Clinical Trial Status

Clinical Trial Status for amlexanox
Clinical Trial Phase Trials
Completed 2
Suspended 1
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Clinical Trial Sponsors for amlexanox

Sponsor Name

Sponsor Name for amlexanox
Sponsor Trials
University of Michigan 2
Advanced Clinical Research Services, LLC 1
Access Pharmaceuticals, Inc. 1
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Sponsor Type

Sponsor Type for amlexanox
Sponsor Trials
Other 3
Industry 1
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