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

Venous Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211898
• Other study ID #: 1138.6
• Status: Completed
• Phase: Phase 3
• First received: August 7, 2014
• Last updated: August 7, 2014
• Start date: July 2004

Study information

• Verified date: August 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Venous Insufficiency

Intervention

Drug:
• BNS003

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Number of patients with adverse drug reactions		up to week 12	No
Secondary	Improvement per symptom on a five point scale		12 weeks	No
Secondary	Change in circumference measurements of calf in centimetres		baseline, 12 weeks	No
Secondary	Change in circumference measurements of ankle in centimetres		baseline, 12 weeks	No
Secondary	Subject's impression on improvement on a five point scale		baseline, 12 weeks	No
Secondary	Number of patients with of adverse events		up to 12 weeks	No

External Links

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