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This clinical trial is a multi-center, double-blind, randomized, active controlled , parallel design, non-inferiority phase 4 study to evaluate the efficacy and safety of Entelon 150mg in 278 patients with chronic venous disease.
This study is to prove that Entelon tab. 150mg is non-inferior in clinical efficacy and safety compared to Venitol tab. for 8 weeks in patients suffering from chronic venous disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entelon Tab.150mg | Experimental |
| |
| Venitol tab. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entelon Tab.150mg | Drug | twice daily for 8 weeks |
|
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| Measure | Description | Time Frame |
|---|---|---|
| CIVIQ-20 questionnaire score change | Change at week 8 of treatment with the drug from baseline(day 0) in CIVIQ-20 questionnaire score | 8week(Visit 4) |
| Measure | Description | Time Frame |
|---|---|---|
| CIVIQ-20 questionnaire score change | Change at week 4 of treatment with the drug from baseline(day 0) in CIVIQ-20 questionnaire score | 4week(Visit 3) |
| AVVQ questionnaire score change | Change at week 4, 8 of treatment with the drug from baseline(day 0) in AVVQ questionnaire score |
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Inclusion Criteria:
19 years ≤ age ≤ 80 years
Those who are diagnosed as CEAP Classification Class 1 ~ Class 3
Those who have the Venous Duplex ultrasonography result at least one of the following
Those who have completed the washout period as following until the baseline, including the screening period
Those who provide written consent voluntarily to participate in this clinical trial
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nahyun Kang | Contact | 82-2-3489-6298 | nahyun.kang@hanlim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bundang Seoul University Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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| Venitol Tab. | Drug | twice daily for 8 weeks |
|
|
| Placebo of Venitol Tab. | Drug | twice daily for 8 weeks (with Entelon Tab.150mg. It is for the masking.) |
|
| Placebo of Entelon Tab.150mg | Drug | twice daily for 8 weeks(with Venitol Tab. It is for the masking.) |
|
| 4week(Visit 3), 8week(Visit 4) |
| 100mm VAS score change of leg heaviness, leg pain, leg cramps | Change at week 4, 8 of treatment with the drug from baseline(day 0) in symptoms of leg heaviness, leg pain, leg cramps thorugh 100mm VAS score | 4week(Visit 3), 8week(Visit 4) |
| Venous clinical severity score change | change at week 4, 8 of treatment with the drug from baseline(day 0) in Venous clinical severity score | 4week(Visit 3), 8week(Visit 4) |
| change in the circumference of the leg due to edema | change at week 8 of treatment with the drug from baseline(day 0) in leg circumference | 8week(Visit 4) |
| ID | Term |
|---|---|
| C080675 | S 5682 |
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