Phase 4 Study to Evaluate Efficacy and Safety of Entelon Tab.150mg in Patients With Chronic Venous Disease(CVD)

Phase 4

• Conditions: Chronic Venous Disease
• Interventions: Drug: Venitol Tab.; Drug: Entelon Tab.150mg; Drug: Placebo of Venitol Tab.; Drug: Placebo of Entelon Tab.150mg

• Registration Number: NCT04882228
• Lead Sponsor: Hanlim Pharm. Co., Ltd.

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.

Study Timeline

• Study Start: 2021-01-28
• Status Verified: 2021-04
• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Last Update Submitted: 2021-05-06
• Study First Posted: 2021-05-11
• Last Update Posted: 2021-05-11
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 278

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entelon Tab.150mg	Placebo of Venitol Tab.	-
Venitol tab.	Venitol Tab.	-
Venitol tab.	Placebo of Entelon Tab.150mg	-
Entelon Tab.150mg	Entelon Tab.150mg	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Bundang Seoul University Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of