Chronic Venous DiseasePhase 4NCT04882228
Phase 4 Study to Evaluate Efficacy and Safety of Entelon Tab.150mg in Patients With Chronic Venous Disease(CVD)
A Phase 4 study testing Entelon Tab.150mg and Venitol Tab. in people with Chronic Venous Disease, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Chronic Venous Disease
- What is being tested?
- Entelon Tab.150mg and Venitol Tab.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Jan 2021to 28 Feb 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Bundang Seoul University Hospital
Seongnam-si, Gyeonggi-do, 13620
Taeseung Lee, Ph.D, tslee@snubh.org
About this study
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)
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.
Read the 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
- Being tested
- Entelon Tab.150mg, Venitol Tab., Placebo of Venitol Tab., Placebo of Entelon Tab.150mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entelon Tab.150mgDrug
Also called Vitis Vinifera Seed Dreid Extract 150mg
twice daily for 8 weeks
Venitol Tab.Drug
Also called Purified and Micronized Flavonoid Fraction 500mg
twice daily for 8 weeks
Placebo of Venitol Tab.Drug
twice daily for 8 weeks (with Entelon Tab.150mg. It is for the masking.)
Placebo of Entelon Tab.150mgDrug
twice daily for 8 weeks(with Venitol Tab. It is for the masking.)
| Study group | Role | What they receive |
|---|---|---|
| Entelon Tab.150mg | Experimental | Not described Receives: Drug: Entelon Tab.150mg; Drug: Placebo of Venitol Tab. |
| Venitol tab. | Active comparator | Not described Receives: Drug: Venitol Tab.; Drug: Placebo of Entelon Tab.150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIVIQ-20 questionnaire score change
Change at week 8 of treatment with the drug from baseline(day 0) in CIVIQ-20 questionnaire score
Measured: 8week(Visit 4)
Secondary outcomes (5)
CIVIQ-20 questionnaire score change
Change at week 4 of treatment with the drug from baseline(day 0) in CIVIQ-20 questionnaire score
Measured: 4week(Visit 3)
AVVQ questionnaire score change
Change at week 4, 8 of treatment with the drug from baseline(day 0) in AVVQ questionnaire score
Measured: 4week(Visit 3), 8week(Visit 4)
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
Measured: 4week(Visit 3), 8week(Visit 4)
Venous clinical severity score change
change at week 4, 8 of treatment with the drug from baseline(day 0) in Venous clinical severity score
Measured: 4week(Visit 3), 8week(Visit 4)
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
Measured: 8week(Visit 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start28 Jan 2021
- Primary completion28 Feb 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 278 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882228
- Sponsor's protocol ID
- HL_ENTL_401
- Status last verified
- Apr 2021
- First submitted
- 6 May 2021
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04882228
- Acronym / sponsor ID
- HL_ENTL_401
- Conditions
- Chronic Venous Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 278 participants (estimated)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 11 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Those who have completed the washout period as following until the baseline, including the screening period
- Those who provide written consent voluntarily to participate in this clinical trial
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entelon Tab.150mgAlso: Vitis Vinifera Seed Dreid Extract 150mgtwice daily for 8 weeks | Drug | Entelon Tab.150mg |
| Venitol Tab.Also: Purified and Micronized Flavonoid Fraction 500mgtwice daily for 8 weeks | Drug | Venitol tab. |
| Placebo of Venitol Tab.twice daily for 8 weeks (with Entelon Tab.150mg. It is for the masking.) | Drug | Entelon Tab.150mg |
| Placebo of Entelon Tab.150mgtwice daily for 8 weeks(with Venitol Tab. It is for the masking.) | Drug | Venitol tab. |
Primary outcome
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
5 secondary outcomes
CIVIQ-20 questionnaire score change
Time frame: 4week(Visit 3)
AVVQ questionnaire score change
Time frame: 4week(Visit 3), 8week(Visit 4)
100mm VAS score change of leg heaviness, leg pain, leg cramps
Time frame: 4week(Visit 3), 8week(Visit 4)
Venous clinical severity score change
Time frame: 4week(Visit 3), 8week(Visit 4)
change in the circumference of the leg due to edema
Time frame: 8week(Visit 4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Entelon Tab.150mg and Venitol Tab. in people with Chronic Venous Disease, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nahyun Kang (82-2-3489-6298, nahyun.kang@hanlim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIVIQ-20 questionnaire score change (time frame: 8week(Visit 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.