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

Chronic Venous Disease Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04882228
• Other study ID #: HL_ENTL_401
• Status: Recruiting
• Phase: Phase 4
• Start date: January 28, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: April 2021
• Source: Hanlim Pharm. Co., Ltd.
• Contact: Nahyun Kang
• Phone: 82-2-3489-6298
• Email: nahyun.kang[@]hanlim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 278
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Venous Disease

Intervention

Drug:
• Entelon Tab.150mg
twice daily for 8 weeks
• Venitol Tab.
twice daily for 8 weeks
• Placebo of Venitol Tab.
twice daily for 8 weeks (with Entelon Tab.150mg. It is for the masking.)
• Placebo of Entelon Tab.150mg
twice daily for 8 weeks(with Venitol Tab. It is for the masking.)

Locations

Country	Name	City	State
Korea, Republic of	Bundang Seoul University Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)