- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01428076
Pharmacokinetic Study of Polidocanol Endovenous Microfoam (PEM)
April 19, 2021 updated by: Boston Scientific Corporation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
21
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
-
Bradenton, Florida, United States, 34209
- Cardiovascular and Vein Center of Florida
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: High Dose Polidocanol Endovenous Microfoam
|
Pharmacokinetic comparison of different doses of drug
|
EXPERIMENTAL: Medium Dose Polidocanol Endovenous Microfoam
|
Pharmacokinetic comparison of different doses of drug
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (ACTUAL)
January 1, 2012
Study Completion (ACTUAL)
January 1, 2012
Study Registration Dates
First Submitted
August 30, 2011
First Submitted That Met QC Criteria
September 1, 2011
First Posted (ESTIMATE)
September 2, 2011
Study Record Updates
Last Update Posted (ACTUAL)
April 21, 2021
Last Update Submitted That Met QC Criteria
April 19, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VAP.VV008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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