Varicose VeinsPhase 1NCT01428076
Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)
A Phase 1 study testing Polidocanol Endovenous Microfoam (PEM) in people with Varicose Veins, run by Boston Scientific Corporation at 1 site in United States.
Trial summary
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Polidocanol Endovenous Microfoam (PEM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Jan 2012
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female; age 18 to 75 years
- Superficial venous disease where SFJ incompetence is the predominant source of reflux (reflux > 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (GSV) or other major accessory vein
- Expected need for microfoam of 10 mL to fill the incompetent GSV and tributaries (minimum trunk vein diameter of 6mm)
- Clinically normal renal and hepatic function on serum chemistry
- Ability to comprehend and sign an informed consent document in English
Who cannot join
- Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
- Clinically significant abnormal ECG or clinical condition which may affect interpretation of ECG, for example, history of Long QT Syndrome, Brugada Syndrome, electronic cardiac pacemaker, chronic atrial fibrillation, recent myocardial infarction or congestive heart failure.
- Patients taking QT prolonging medications
- Any of the following findings on screening ECG:
- QRS > 110 ms
- HR < 45 bpm
Show all 23Show fewer
- HR > 100 bpm
- QTcF > 470 ms
- PR > 220 ms
- Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP Classification of Venous Disorders)
- Leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure compression bandaging and stockings
- Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
- Deep venous reflux unless clinically insignificant in comparison to superficial reflux
- Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
- Reduced mobility (unable to walk unaided for 5 minutes per waking hour)
- History of deep vein thrombosis, pulmonary embolism or stroke, including evidence of prior DVT on duplex ultrasound
- Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
- Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions
- Current alcohol or drug abuse
- Pregnant or lactating women
- Women of childbearing potential not using effective contraception for at least one month prior to study enrollment (i.e., treatment) and/or unwilling to continue birth control until Visit 4
- Participation in a clinical study involving an investigational pharmaceutical product or device within the 3 months prior to screening
- Previous treatment with Polidocanol Endovenous Microfoam (PEM) in a previous PEM study
Trial locations and contacts
1 site in 1 country.
United States1 site
Cardiovascular and Vein Center of Florida
Bradenton, Florida, 34209
About this study
Official title: An Open-Label Single-Center Study in Patients With Great Saphenous Vein Incompetence to Investigate the Pharmacokinetic Properties of Polidocanol Endovenous Microfoam (PEM)
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the pharmacokinetic profile of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM), an investigational treatment for varicose veins.
- Conditions
- Varicose Veins
- Being tested
- Polidocanol Endovenous Microfoam (PEM)
- Keywords
- Varicose Veins, SFJ Reflux
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polidocanol Endovenous Microfoam (PEM)Drug
Pharmacokinetic comparison of different doses of drug
| Study group | Role | What they receive |
|---|---|---|
| High Dose Polidocanol Endovenous Microfoam | Experimental | Not described Receives: Drug: Polidocanol Endovenous Microfoam (PEM) |
| Medium Dose Polidocanol Endovenous Microfoam | Experimental | Not described Receives: Drug: Polidocanol Endovenous Microfoam (PEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight-adjusted Polidocanol Cmax (Serum)
Cmax measured and adjusted for weight
Measured: pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BTG International Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428076
- Sponsor's protocol ID
- VAP.VV008
- Status last verified
- Apr 2021
- First submitted
- 30 Aug 2011
- Last updated
- 21 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Single-Center Study in Patients With Great Saphenous Vein Incompetence to Investigate the Pharmacokinetic Properties of Polidocanol Endovenous Microfoam (PEM)
- ClinicalTrials.gov ID
- NCT01428076
- Acronym / sponsor ID
- VAP.VV008
- Conditions
- Varicose Veins
- Keywords
- Varicose Veins, SFJ Reflux
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- BTG International Inc.
- Study start
- Aug 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Sep 2011 (estimated)
- Results
- Posted 31 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the pharmacokinetic profile of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM), an investigational treatment for varicose veins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Dose Polidocanol Endovenous Microfoam | Experimental | Drug: Polidocanol Endovenous Microfoam (PEM) |
| Medium Dose Polidocanol Endovenous Microfoam | Experimental | Drug: Polidocanol Endovenous Microfoam (PEM) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female; age 18 to 75 years
- Superficial venous disease where SFJ incompetence is the predominant source of reflux (reflux > 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (GSV) or other major accessory vein
- Expected need for microfoam of 10 mL to fill the incompetent GSV and tributaries (minimum trunk vein diameter of 6mm)
- Clinically normal renal and hepatic function on serum chemistry
- Ability to comprehend and sign an informed consent document in English
Key exclusion criteria (23 listed)
- Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
- Clinically significant abnormal ECG or clinical condition which may affect interpretation of ECG, for example, history of Long QT Syndrome, Brugada Syndrome, electronic cardiac pacemaker, chronic atrial fibrillation, recent myocardial infarction or congestive heart failure.
- Patients taking QT prolonging medications
- Any of the following findings on screening ECG:
- QRS > 110 ms
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 |
|---|---|---|
| Polidocanol Endovenous Microfoam (PEM)Pharmacokinetic comparison of different doses of drug | Drug | High Dose Polidocanol Endovenous Microfoam, Medium Dose Polidocanol Endovenous Microfoam |
Primary outcome
Weight-adjusted Polidocanol Cmax (Serum)
Time frame: pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose
Cmax measured and adjusted for weight
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Polidocanol Endovenous Microfoam (PEM) in people with Varicose Veins, run by Boston Scientific Corporation at 1 site in United States.
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 5 inclusion and 23 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 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight-adjusted Polidocanol Cmax (Serum) (time frame: pharmacokinetics measured- predose, 1, 4, 5, 7, 9, 11, 14, 15, 17, 20, 25, 30 minutes post dose, 1, 2, 3, 4, 5, 6, 8 hours post dose). 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 21 Apr 2021.