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

NCT ID: NCT04882228

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 278 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-28
• Study Completion Date: 2022-02-28

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.

Conditions

Chronic Venous Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Entelon Tab.150mg

Group Type: EXPERIMENTAL

Entelon Tab.150mg

Intervention Type: DRUG

twice daily for 8 weeks

Placebo of Venitol Tab.

Intervention Type: DRUG

twice daily for 8 weeks (with Entelon Tab.150mg. It is for the masking.)

Venitol tab.

Group Type: ACTIVE_COMPARATOR

Venitol Tab.

Intervention Type: DRUG

twice daily for 8 weeks

Placebo of Entelon Tab.150mg

Intervention Type: DRUG

twice daily for 8 weeks(with Venitol Tab. It is for the masking.)

Interventions

Entelon Tab.150mg

twice daily for 8 weeks

Intervention Type: DRUG

Venitol Tab.

twice daily for 8 weeks

Intervention Type: DRUG

Placebo of Venitol Tab.

twice daily for 8 weeks (with Entelon Tab.150mg. It is for the masking.)

Intervention Type: DRUG

Placebo of Entelon Tab.150mg

twice daily for 8 weeks(with Venitol Tab. It is for the masking.)

Intervention Type: DRUG

Other Intervention Names

Vitis Vinifera Seed Dreid Extract 150mg; Purified and Micronized Flavonoid Fraction 500mg

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanlim Pharm. Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Bundang Seoul University Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Nahyun Kang

Role: CONTACT

nahyun.kang@hanlim.com

82-2-3489-6298

Facility Contacts

Taeseung Lee, Ph.D

Role: primary

tslee@snubh.org

Other Identifiers

HL_ENTL_401

Identifier Type: -

Identifier Source: org_study_id