Varicose Veins
Conditions
Keywords
Varicose Veins, SFJ Reflux
Brief 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. 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.
Interventions
Pharmacokinetic comparison of different doses of drug
Sponsors
BTG International Inc.
Boston Scientific Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight-adjusted Polidocanol Cmax (Serum) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Polidocanol 1% polidocanol injectable foam 1% concentration | 9 |
| Polidocanol 2% polidocanol intravenous foam 2% concentration | 12 |
| Total | 21 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Polidocanol 1% | Polidocanol 2% | Total |
|---|---|---|---|
| Age, Continuous | 54.0 years STANDARD_DEVIATION 9.62 | 49.9 years STANDARD_DEVIATION 11.4 | 51.7 years STANDARD_DEVIATION 10.6 |
| BMI | 27.1 kg/m^2 STANDARD_DEVIATION 2.52 | 27.1 kg/m^2 STANDARD_DEVIATION 5.19 | 27.1 kg/m^2 STANDARD_DEVIATION 4.16 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 12 Participants | 21 Participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 9 | 5 / 12 |
| serious Total, serious adverse events | 0 / 9 | 0 / 12 |
Outcome results
Primary
Weight-adjusted Polidocanol Cmax (Serum)
Cmax measured and adjusted for weight
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
Population: PK population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Males-polidocanol 1% | Weight-adjusted Polidocanol Cmax (Serum) | 584.1 ng/mL | Standard Deviation 142.8 |
| Males-polidocanol 2% | Weight-adjusted Polidocanol Cmax (Serum) | 1188.7 ng/mL | Standard Deviation 341.7 |
| Females-polidocanol 1% | Weight-adjusted Polidocanol Cmax (Serum) | 840.7 ng/mL | Standard Deviation 437.6 |
| Females- Polidocanol 2% | Weight-adjusted Polidocanol Cmax (Serum) | 1189.6 ng/mL | Standard Deviation 331.2 |