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

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ClinicalTrials.gov Identifier: NCT02211898
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

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.

Condition or disease Intervention/treatment Phase
Venous Insufficiency Drug: BNS003 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of BNS003 on Swelling Due to Disorder of Leg Venous Reflux
Study Start Date : July 2004
Actual Primary Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: BNS003 Drug: BNS003



Primary Outcome Measures :
  1. Global improvement on a five point scale [ Time Frame: week 12 ]
    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)

  2. Number of patients with adverse drug reactions [ Time Frame: up to week 12 ]

Secondary Outcome Measures :
  1. Improvement per symptom on a five point scale [ Time Frame: 12 weeks ]
  2. Change in circumference measurements of calf in centimetres [ Time Frame: baseline, 12 weeks ]
  3. Change in circumference measurements of ankle in centimetres [ Time Frame: baseline, 12 weeks ]
  4. Subject's impression on improvement on a five point scale [ Time Frame: baseline, 12 weeks ]
  5. Number of patients with of adverse events [ Time Frame: up to 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02211898     History of Changes
Other Study ID Numbers: 1138.6
First Posted: August 8, 2014    Key Record Dates
Last Update Posted: August 8, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases