Status:
UNKNOWN
Phase 4 Study to Evaluate Efficacy and Safety of Entelon Tab.150mg in Patients With Chronic Venous Disease(CVD)
Lead Sponsor:
Hanlim Pharm. Co., Ltd.
Conditions:
Chronic Venous Disease
Eligibility:
All Genders
19-80 years
Phase:
PHASE4
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...
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.
Eligibility Criteria
Inclusion
- 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
- 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
- Those who do not agree to use an effective method of contraception
- Individual considered by the investigator to be ineligible for study participation
Key Trial Info
Start Date :
January 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2022
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT04882228
Start Date
January 28 2021
End Date
February 28 2022
Last Update
May 11 2021
Active Locations (1)
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1
Bundang Seoul University Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620