Chronic Venous Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGVenitol Tab.
twice daily for 8 weeks
DRUGEntelon Tab.150mg
twice daily for 8 weeks
DRUGPlacebo of Venitol Tab.
twice daily for 8 weeks (with Entelon Tab.150mg. It is for the masking.)
DRUGPlacebo of Entelon Tab.150mg
twice daily for 8 weeks(with Venitol Tab. It is for the masking.)
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 19 years ≤ age ≤ 80 years 2. Those who are diagnosed as CEAP Classification Class 1 \ Class 3 3. Those who have the Venous Duplex ultrasonography result at least one of the following * reflux more than 1 second in Femoral vein or Popliteal vein * reflux more that 0.5 second in GSV or SSV or Accessory saphenous vein or perforating vein or calf vein 4. Those who have completed the washout period as following until the baseline, including the screening period * Analgesic, corticosteroids, anti-inflammatory drugs: at least 2 weeks 5. Those who provide written consent voluntarily to participate in this clinical trial
Exclusion criteria
1. Those who must wear compression stockings 2. Those who have obstruction of the peripheral arteries of the lower extremities 3. Those who have asymptomatic varicose veins 4. Those who have acute deep vein thrombosis 5. Those who have frequent lower extremity pain due to neuropathy 6. Varicose vein surgery patient or prospective person (if surgery was done more than 1 year prior to the time of screening, recruitment is possible) 7. Those who have systemic disease that causes edema or thrombosis 8. Those who have a history of malignant tumors within 5 years prior to the time of screening 9. Those who have severe renal dysfunction at the time of screening (serum creatinine ≥ 2 x upper limit of normal) 10. Those who have severe liver dysfunction at the time of screening (AST or ALT ≥ 3 x upper limit of normal) 11. Those who are required to receive diuretics, analgesics, corticosteroids, anti-inflammatory drugs, or contraindications that may affect the outcome of this clinical trial during the clinical trial period 12. Those who have a history of significant mental illness, alcohol abuse 13. Patients who have an allergy to investigational product or any of its excipients 14. Patients who participated in other clinical trials within 12 weeks prior to the date of screening 15. Pregnant or lactating woman 16. Those who do not agree to use an effective method of contraception 17. Individual considered by the investigator to be ineligible for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CIVIQ-20 questionnaire score change | 8week(Visit 4) | Change at week 8 of treatment with the drug from baseline(day 0) in CIVIQ-20 questionnaire score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CIVIQ-20 questionnaire score change | 4week(Visit 3) | Change at week 4 of treatment with the drug from baseline(day 0) in CIVIQ-20 questionnaire score |
| AVVQ questionnaire score change | 4week(Visit 3), 8week(Visit 4) | Change at week 4, 8 of treatment with the drug from baseline(day 0) in AVVQ questionnaire score |
| 100mm VAS score change of leg heaviness, leg pain, leg cramps | 4week(Visit 3), 8week(Visit 4) | 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 |
| Venous clinical severity score change | 4week(Visit 3), 8week(Visit 4) | change at week 4, 8 of treatment with the drug from baseline(day 0) in Venous clinical severity score |
| change in the circumference of the leg due to edema | 8week(Visit 4) | change at week 8 of treatment with the drug from baseline(day 0) in leg circumference |
Countries
South Korea
Contacts
Primary ContactNahyun Kang
Outcome results
None listed