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Last Updated: December 22, 2024

CLINICAL TRIALS PROFILE FOR BENYLIN


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All Clinical Trials for BENYLIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01441102 ↗ Dextromethorphan for Diabetic Macular Edema Completed The Emmes Company, LLC Phase 1/Phase 2 2011-08-01 Background: Many people with diabetes have macular edema (swelling) at the back of the eye. Macular edema can cause loss of vision. Studies suggest that inflammation may be involved in the swelling. A drug called dextromethorphan may help prevent the inflammation and the swelling. Dextromethorphan is approved for use as a cough medicine, but it has not been studied to see if it can help in diabetic macular edema. Objectives: To see if dextromethorphan can help treat diabetic macular edema. Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least one eye. Design: - This study lasts 2 years, and will require at least 14 visits to the National Eye Institute outpatient clinic. Study visits will be every month for the first 2 months and then every other month. Each visit will take about 2 to 4 hours. - Participants will be screened with a physical exam, medical history, eye exam, and blood tests. One eye with macular edema will be chosen as the study eye for testing. - Participants will take dextromethorphan twice a day, about 12 hours apart, for 2 years. A study diary will help keep track of the date, time, and number of pills taken. - Participants will have study visits once a month for the first 2 months and then every other month for the rest of the study. Each study visit will involve eye exams and blood and urine tests. - Four months after starting the study medication, participants may have laser surgery or other treatments for the macular edema, if it is needed.
NCT01441102 ↗ Dextromethorphan for Diabetic Macular Edema Completed The EMMES Corporation Phase 1/Phase 2 2011-08-01 Background: Many people with diabetes have macular edema (swelling) at the back of the eye. Macular edema can cause loss of vision. Studies suggest that inflammation may be involved in the swelling. A drug called dextromethorphan may help prevent the inflammation and the swelling. Dextromethorphan is approved for use as a cough medicine, but it has not been studied to see if it can help in diabetic macular edema. Objectives: To see if dextromethorphan can help treat diabetic macular edema. Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least one eye. Design: - This study lasts 2 years, and will require at least 14 visits to the National Eye Institute outpatient clinic. Study visits will be every month for the first 2 months and then every other month. Each visit will take about 2 to 4 hours. - Participants will be screened with a physical exam, medical history, eye exam, and blood tests. One eye with macular edema will be chosen as the study eye for testing. - Participants will take dextromethorphan twice a day, about 12 hours apart, for 2 years. A study diary will help keep track of the date, time, and number of pills taken. - Participants will have study visits once a month for the first 2 months and then every other month for the rest of the study. Each study visit will involve eye exams and blood and urine tests. - Four months after starting the study medication, participants may have laser surgery or other treatments for the macular edema, if it is needed.
NCT01441102 ↗ Dextromethorphan for Diabetic Macular Edema Completed National Eye Institute (NEI) Phase 1/Phase 2 2011-08-01 Background: Many people with diabetes have macular edema (swelling) at the back of the eye. Macular edema can cause loss of vision. Studies suggest that inflammation may be involved in the swelling. A drug called dextromethorphan may help prevent the inflammation and the swelling. Dextromethorphan is approved for use as a cough medicine, but it has not been studied to see if it can help in diabetic macular edema. Objectives: To see if dextromethorphan can help treat diabetic macular edema. Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least one eye. Design: - This study lasts 2 years, and will require at least 14 visits to the National Eye Institute outpatient clinic. Study visits will be every month for the first 2 months and then every other month. Each visit will take about 2 to 4 hours. - Participants will be screened with a physical exam, medical history, eye exam, and blood tests. One eye with macular edema will be chosen as the study eye for testing. - Participants will take dextromethorphan twice a day, about 12 hours apart, for 2 years. A study diary will help keep track of the date, time, and number of pills taken. - Participants will have study visits once a month for the first 2 months and then every other month for the rest of the study. Each study visit will involve eye exams and blood and urine tests. - Four months after starting the study medication, participants may have laser surgery or other treatments for the macular edema, if it is needed.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for BENYLIN

Condition Name

Condition Name for BENYLIN
Intervention Trials
Diabetic Macular Edema 1
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Condition MeSH

Condition MeSH for BENYLIN
Intervention Trials
Macular Edema 1
Edema 1
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Clinical Trial Locations for BENYLIN

Trials by Country

Trials by Country for BENYLIN
Location Trials
United States 1
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Trials by US State

Trials by US State for BENYLIN
Location Trials
Maryland 1
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Clinical Trial Progress for BENYLIN

Clinical Trial Phase

Clinical Trial Phase for BENYLIN
Clinical Trial Phase Trials
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for BENYLIN
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for BENYLIN

Sponsor Name

Sponsor Name for BENYLIN
Sponsor Trials
The Emmes Company, LLC 1
The EMMES Corporation 1
National Eye Institute (NEI) 1
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Sponsor Type

Sponsor Type for BENYLIN
Sponsor Trials
Industry 2
NIH 1
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