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

Boehringer Ingelheim

Status and phase

Completed

Phase 3

Conditions

Venous Insufficiency

Treatments

Drug: BNS003

Study type

Interventional

Funder types

Industry

Identifiers

NCT02211898

1138.6

Details and patient eligibility

About

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.

Enrollment

180 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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