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)

Hanlim Pharm. Co., Ltd.1 site in 1 country278 target enrollmentJanuary 28, 2021

ConditionsChronic Venous Disease

InterventionsVenitol Tab.Placebo of Entelon Tab.150mg Entelon Tab.150mg Placebo of Venitol Tab.

DrugsEntelon Tab.150mg Venitol Tab.Placebo of Venitol Tab.Placebo of Entelon Tab.150mg

Overview

Phase: Phase 4
Intervention: Venitol Tab.
Conditions: Chronic Venous Disease
Sponsor: Hanlim Pharm. Co., Ltd.
Enrollment: 278
Locations: 1
Primary Endpoint: CIVIQ-20 questionnaire score change
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 28, 2021

End Date

February 28, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hanlim Pharm. Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•19 years ≤ age ≤ 80 years
•Those who are diagnosed as CEAP Classification Class 1 \~ Class 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
•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
•Those who provide written consent voluntarily to participate in this clinical trial

Exclusion Criteria

•Those who must wear compression stockings
•Those who have obstruction of the peripheral arteries of the lower extremities
•Those who have asymptomatic varicose veins
•Those who have acute deep vein thrombosis
•Those who have frequent lower extremity pain due to neuropathy
•Varicose vein surgery patient or prospective person (if surgery was done more than 1 year prior to the time of screening, recruitment is possible)
•Those who have systemic disease that causes edema or thrombosis
•Those who have a history of malignant tumors within 5 years prior to the time of screening
•Those who have severe renal dysfunction at the time of screening (serum creatinine ≥ 2 x upper limit of normal)
•Those who have severe liver dysfunction at the time of screening (AST or ALT ≥ 3 x upper limit of normal)

Arms & Interventions

Venitol tab.

Intervention: Venitol Tab.

Venitol tab.

Intervention: Placebo of Entelon Tab.150mg

Entelon Tab.150mg

Intervention: Entelon Tab.150mg

Entelon Tab.150mg

Intervention: Placebo of Venitol Tab.

Outcomes

Primary Outcomes

CIVIQ-20 questionnaire score change

Time Frame: 8week(Visit 4)

Change at week 8 of treatment with the drug from baseline(day 0) in CIVIQ-20 questionnaire score

Secondary Outcomes

100mm VAS score change of leg heaviness, leg pain, leg cramps(4week(Visit 3), 8week(Visit 4))
Venous clinical severity score change(4week(Visit 3), 8week(Visit 4))
CIVIQ-20 questionnaire score change(4week(Visit 3))
change in the circumference of the leg due to edema(8week(Visit 4))
AVVQ questionnaire score change(4week(Visit 3), 8week(Visit 4))