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

NCT04882228 | Unknown Phase 4

• 1 other identifier: HL_ENTL_401
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Venous Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• CIVIQ-20 questionnaire score change

  4week(Visit 3)

• AVVQ questionnaire score change

  4week(Visit 3), 8week(Visit 4)

• 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)

• change in the circumference of the leg due to edema

  8week(Visit 4)

Study Arms (2)

Entelon Tab.150mg

EXPERIMENTAL

Drug: Entelon Tab.150mg; Drug: Placebo of Venitol Tab.

Venitol tab.

ACTIVE COMPARATOR

Drug: Venitol Tab.; Drug: Placebo of Entelon Tab.150mg

Interventions

Entelon Tab.150mg DRUG

twice daily for 8 weeks

Also known as: Vitis Vinifera Seed Dreid Extract 150mg

Entelon Tab.150mg

Venitol Tab. DRUG

twice daily for 8 weeks

Also known as: Purified and Micronized Flavonoid Fraction 500mg

Venitol tab.

Placebo of Venitol Tab. DRUG

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

Entelon Tab.150mg

Placebo of Entelon Tab.150mg DRUG

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

Venitol tab.

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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
• Those who have a history of significant mental illness, alcohol abuse
• Patients who have an allergy to investigational product or any of its excipients
• Patients who participated in other clinical trials within 12 weeks prior to the date of screening
• Pregnant or lactating woman

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Bundang Seoul University Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

MeSH Terms

Interventions

S 5682

Central Study Contacts

Nahyun Kang

CONTACT

82-2-3489-6298; nahyun.kang@hanlim.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 11, 2021
• Study Start: January 28, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: May 11, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)