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

Primary Purpose

Venous Insufficiency

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BNS003
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Insufficiency

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    BNS003

    Arm Description

    Outcomes

    Primary Outcome Measures

    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)
    Number of patients with adverse drug reactions

    Secondary Outcome Measures

    Improvement per symptom on a five point scale
    Change in circumference measurements of calf in centimetres
    Change in circumference measurements of ankle in centimetres
    Subject's impression on improvement on a five point scale
    Number of patients with of adverse events

    Full Information

    First Posted
    August 7, 2014
    Last Updated
    August 7, 2014
    Sponsor
    Boehringer Ingelheim
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02211898
    Brief Title
    Clinical Study of BNS003 on Swelling in Legs Due to Venous Reflux
    Official Title
    Clinical Study of BNS003 on Swelling Due to Disorder of Leg Venous Reflux
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    January 2005 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boehringer Ingelheim

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Venous Insufficiency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    180 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BNS003
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    BNS003
    Primary Outcome Measure Information:
    Title
    Global improvement on a five point scale
    Description
    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)
    Time Frame
    week 12
    Title
    Number of patients with adverse drug reactions
    Time Frame
    up to week 12
    Secondary Outcome Measure Information:
    Title
    Improvement per symptom on a five point scale
    Time Frame
    12 weeks
    Title
    Change in circumference measurements of calf in centimetres
    Time Frame
    baseline, 12 weeks
    Title
    Change in circumference measurements of ankle in centimetres
    Time Frame
    baseline, 12 weeks
    Title
    Subject's impression on improvement on a five point scale
    Time Frame
    baseline, 12 weeks
    Title
    Number of patients with of adverse events
    Time Frame
    up to 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Links:
    URL
    http://trials.boehringer-ingelheim.com
    Description
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