Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins

Chronic Venous Insufficiency Clinical Trial

Official title:

Evaluate the Efficacy and Safety of Esarin Gel in the Treatment of Chronic Venous Insufficiency or Varicose Vein Combine With Superficial Vein Thrombophlebitis in Outpatient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02346058
• Other study ID #: SF13136A
• Status: Completed
• Phase: Phase 4
• First received: January 13, 2015
• Last updated: January 19, 2015
• Start date: October 2013
• Est. completion date: October 2014

Study information

• Verified date: June 2013
• Source: Ten Sun Pharma Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Evaluation efficacy and safety of Esarin Gel in subjects with chronic venous insufficiency or varicose veins combine superficial vein thrombophlebitis.

Description:

Open-label,non-controlled study design with three visits (pre-treatment/baseline, treatment day 14 and day 28). Administered Esarin Gel twice daily for 28 days in subjects with chronic venous insufficiency rated between CEAP 0 and 3 or varicose veins combine superficial vein thrombophlebitis, in comparison to the pre-treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

1. Inclusion Criteria:

• Patients of both sexes, aged above 20 years old.

• The patient has confirmed his/her willingness to participate in the study, after being informed about all the aspects of the study that might be relevant for his/her decision to participate, and has signed and dated the informed consent form, as approved by the Institutional Review Board/ Ethics Committee (IRB/EC).

• Presence of chronic venous insufficiency which is rated between functional classes CEAP 0 and 3.(CEAP Classes: C0:no visible or palpable signs of venous disease, C1:telangiectasies or reticular veins. C2 :apparent Varicose veins, C3 :Edema)

• Diagnosed with superficial vein thrombophlebitis and have skin reaction by redness, swelling, fever and pain symptoms.

2. Exclusion Criteria:

• Known allergy to the product's ingredients

• pregnant or breastfeeding

• patient is joining to any other clinical trail

• Patient has not sign the informed consent form

• Deep vein thrombosis

• Cellulitis

• Stasis dermatitis

• The patient is taking non-steroids anti-inflammatory drugs( include oral ,topical creams or patch form)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Venous Insufficiency
• Superficial Vein Thrombophlebitis
• Thrombophlebitis
• Varicose Vein
• Varicose Veins
• Venous Insufficiency

Intervention

Drug:
• Esarin Gel

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung

Sponsors (1)

Lead Sponsor	Collaborator
Ten Sun Pharma Company Limited

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in subject's leg swelling	Change from pre-treatment (baseline) in the thigh circumference on treatment day 14 and day 28. Using the tape measure to measure the thigh circumference.	28 days	No
Primary	Change in subject's leg pain	Change from pre-treatment (baseline) in subject's leg pain on treatment day 14 and day 28. For the assessment of pain, a numerical rating scale (0-10; 0(zero) meaning "no pain" and 10 (ten) "the worst pain") is used.	28 days	No
Secondary	Safety Assessment through the adverse events reports		28 days	Yes
Secondary	Improvement of patient's quality of life	Improvement of patient's general activities, mood and sleeping from pre-treatment (baseline) to day 14 and day 28 during Esarin Gel treatment period.	28 days	No