Venous InsufficiencyPhase 3NCT02211898
Clinical Study of BNS003 on Swelling in Legs Due to Venous Reflux
A Phase 3 study testing BNS003 in people with Venous Insufficiency, run by Boehringer Ingelheim.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Venous Insufficiency
- What is being tested?
- BNS003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Jan 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
About this study
Official title: Clinical Study of BNS003 on Swelling Due to Disorder of Leg Venous Reflux
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
- Being tested
- BNS003
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNS003Drug
| Study group | Role | What they receive |
|---|---|---|
| BNS003 | Experimental | Not described Receives: Drug: BNS003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: week 12
Number of patients with adverse drug reactions
Measured: up to week 12
Secondary outcomes (5)
Improvement per symptom on a five point scale
Measured: 12 weeks
Change in circumference measurements of calf in centimetres
Measured: baseline, 12 weeks
Change in circumference measurements of ankle in centimetres
Measured: baseline, 12 weeks
Subject's impression on improvement on a five point scale
Measured: baseline, 12 weeks
Number of patients with of adverse events
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startJul 2004
- Primary completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous InsufficiencyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211898
- Sponsor's protocol ID
- 1138.6
- Status last verified
- Aug 2014
- First submitted
- 7 Aug 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of BNS003 on Swelling Due to Disorder of Leg Venous Reflux
- ClinicalTrials.gov ID
- NCT02211898
- Acronym / sponsor ID
- 1138.6
- Conditions
- Venous Insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Jan 2005 (actual)
- First posted
- 8 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BNS003 | Experimental | Drug: BNS003 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNS003 | Drug | BNS003 |
Primary outcome
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)
Number of patients with adverse drug reactions
Time frame: up to week 12
5 secondary outcomes
Improvement per symptom on a five point scale
Time frame: 12 weeks
Change in circumference measurements of calf in centimetres
Time frame: baseline, 12 weeks
Change in circumference measurements of ankle in centimetres
Time frame: baseline, 12 weeks
Subject's impression on improvement on a five point scale
Time frame: baseline, 12 weeks
Number of patients with of adverse events
Time frame: up to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BNS003 in people with Venous Insufficiency, run by Boehringer Ingelheim.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global improvement on a five point scale (time frame: week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2014.