Clinical Study of BNS003 on Swelling in Legs Due to Venous Reflux

Study Overview
=================
Brief Summary
-----------------
To investigate the efficacy and safety of BNS003 on subjective symptoms such as sensation of heaviness/tiredness(dullness), tension, tingling, pain, fever or itching associated with swelling of calf and ankle due to disorder of leg venous reflux.

Official Title
-----------------
Clinical Study of BNS003 on Swelling Due to Disorder of Leg Venous Reflux

Conditions
-----------------
Venous Insufficiency

Intervention / Treatment
-----------------
* Drug: BNS003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Manifestation of swelling falling into Class 1 according to Porter's classification With more than 2 symptoms of sensation of heaviness/tiredness (dullness), tension, tingling, pain, fever or itching and a total score of >=3 for severity by symptoms Persons aged 20 years or older at the time of obtaining their informed consent and available for hospital visits. Both genders are acceptable Persons who have consented to participating in the study in written form with good understanding of the objective of the study, the methods, and notices for the study period Exclusion Criteria: Persons with edema not due to venous diseases of the legs (e.g., lymphedema, latent cardiac or renal insufficiency, etc.) Persons with peripheral arterial diseases Persons with acute phlebitis, venous ulcer, congenital vascular anomaly, or Behcet's Syndrome Persons with moderate or severe renal, hepatic, cardiac or haematological disorder, or with a history of such disorder (Grade 3 or 4 in Common Toxicity Criteria (CTC)) Persons with diabetes mellitus (excluding those curable with dietary therapy), neuropathy, hyper-or hypocalcemia, or malignant tumors Persons with drug or alcohol abuse Persons with immobility Persons with pulmonary embolism Persons with hypersensitivity to drugs (particularly to the ingredients contained in the investigational drug) Persons with clinical indication of requiring venous treatment such as physical application (use of elastic bandage and compression stockings) and phlebectomy (vein stripping surgery to remove vein affected with varicosis and valve insufficiency) Persons who received venous sclerosing therapy within the last 4 weeks before starting this study Persons who constantly use theophylline preparations, diuretics, cardiac glycosides Persons who had changed to or initiated post-menopausal hormone replacement therapy within the last 2 months before starting this study Persons unable to suspend the frequent use and exceeded dosage/administration of laxatives (more than 6 times) during the study period Persons planned to undergo a surgery requiring systemic anesthesia during the study period Women in pregnancy or nursing, or those who wish for a pregnancy during the study period Persons who participated in another study within the last 3 months before starting this study, or who plan to participate in another study during the study period Persons who were considered to be ineligible to be a subject for the trial by the investigator or sub-investigators

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BNS003<br> | Drug: BNS003<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global improvement on a five point scale | The degree of improvement was evaluated according to change of severity of each symptom at the time of enrollment (baseline) and in Week 12 after initiation of dosing (or at discontinuation) | week 12 | 
| Number of patients with adverse drug reactions |  | up to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement per symptom on a five point scale |  | 12 weeks | 
| Change in circumference measurements of calf in centimetres |  | baseline, 12 weeks | 
| Change in circumference measurements of ankle in centimetres |  | baseline, 12 weeks | 
| Subject's impression on improvement on a five point scale |  | baseline, 12 weeks | 
| Number of patients with of adverse events |  | up to 12 weeks |