NCT01428076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2011

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

March 31, 2014

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

5 months

First QC Date

August 30, 2011

Results QC Date

January 15, 2014

Last Update Submit

April 19, 2021

Conditions

Varicose Veins

Keywords

Varicose VeinsSFJ Reflux

Outcome Measures

Primary Outcomes (1)

  • Weight-adjusted Polidocanol Cmax (Serum)

    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

Study Arms (2)

High Dose Polidocanol Endovenous Microfoam

EXPERIMENTAL
Drug: Polidocanol Endovenous Microfoam (PEM)

Medium Dose Polidocanol Endovenous Microfoam

EXPERIMENTAL
Drug: Polidocanol Endovenous Microfoam (PEM)

Interventions

Polidocanol Endovenous Microfoam (PEM)DRUG

Pharmacokinetic comparison of different doses of drug

High Dose Polidocanol Endovenous MicrofoamMedium Dose Polidocanol Endovenous Microfoam

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular and Vein Center of Florida

Bradenton, Florida, 34209, United States

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
David Wright MB FRCS
Organization
BTG International Inc.
david.wright@btgplc.com
610-278-1660

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2011

First Posted

September 2, 2011

Study Start

August 1, 2011

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 21, 2021

Results First Posted

March 31, 2014

Record last verified: 2021-04

Locations

US(1)