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

NCT02211898 | Completed Phase 3

• 1 other identifier: 1138.6
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Venous Insufficiency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

BNS003

EXPERIMENTAL

Drug: BNS003

Interventions

BNS003 DRUG

BNS003

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 8, 2014
• Study Start: July 1, 2004
• Primary Completion: January 1, 2005
• Last Updated: August 8, 2014

Record last verified: 2014-08