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

A Multicenter, Double-blind, Randomized, Active Controlled, Parallel Group, Non-inferiority Phase 4 Study to Evaluate Efficacy and Safety of Entelon Tab.150mg in Patients With Chronic Venous Disease(CVD)

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Venous Disease
• Intervention / Treatment: Drug: Entelon Tab.150mg; Drug: Placebo of Venitol Tab.; Drug: Venitol Tab.; Drug: Placebo of Entelon Tab.150mg

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 Type: Interventional
• Enrollment (Anticipated): 278
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Nahyun Kang; Phone Number: 82-2-3489-6298; Email: nahyun.kang@hanlim.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
      • Recruiting
      • Bundang Seoul University Hospital
      • Contact: Taeseung Lee, Ph.D; Email: tslee@snubh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Entelon Tab.150mg	Drug: Entelon Tab.150mg; twice daily for 8 weeks; Other Names: Vitis Vinifera Seed Dreid Extract 150mg; Drug: Placebo of Venitol Tab.; twice daily for 8 weeks (with Entelon Tab.150mg. It is for the masking.)
Active Comparator: Venitol tab.	Drug: Venitol Tab.; twice daily for 8 weeks; Other Names: Purified and Micronized Flavonoid Fraction 500mg; Drug: Placebo of Entelon Tab.150mg; twice daily for 8 weeks(with Venitol Tab. It is for the masking.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2021
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): February 28, 2022

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (Actual): May 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HL_ENTL_401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No