NCT00758420

Brief Summary

The purpose of this study is to evaluate the effectiveness of polidocanol injectable foam in the relief of symptoms, improvement of appearance, and overall effectiveness and safety in the treatment of varicose veins compared to placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

September 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
6 days until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

March 24, 2014

Completed
Last Updated

April 21, 2021

Status Verified

April 1, 2021

Enrollment Period

9 months

First QC Date

September 22, 2008

Results QC Date

January 6, 2014

Last Update Submit

April 19, 2021

Conditions

Varicose Veins

Keywords

Varicose Veins

Outcome Measures

Primary Outcomes (1)

  • The Absolute Change From Baseline Score for the VVSymQ (Total Score) at 8 Weeks

    The VVSymQ is a subset of the VEINES-Sym and consists of the 5 symptoms most relevant to patients. The raw score, which can range from 5 to 30, was transformed to a summary VVSymQ score that ranges from 0 (worst possible symptom health) to 100 (best symptom health) using the following formula: VVSymQ: (Transformed Score) = \[(Raw Score) - 5\] \* 4.

    Baseline to 8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Varisolve (polidocanol endovenous mircofoam)

Drug: Varisolve (Polidocanol Endovenous Microfoam)

2

PLACEBO COMPARATOR

Agitated saline

Drug: Agitated Saline

Interventions

Varisolve (Polidocanol Endovenous Microfoam)DRUG

1% polidocanol, up to 15 mL, one treatment session (initially up to 30 ml, reduced to up to 15 ml in Amendment #2)

1
Agitated SalineDRUG

10 u/mL normal heparinized saline solution, up to 20 mL, one treatment session

2

Eligibility Criteria

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

You may qualify if:

  • Males and Females 18-65 years old
  • VEINES Sym Score less than 75 points
  • Varicose Vein clinical classification CEAP 2, 3, 4, or 5
  • Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
  • Superficial venous disease manifested by both symptoms and visible varicosities
  • Ability to comprehend and sign an informed consent document and completed study questionnaires in English

You may not qualify if:

  • Incompetence of the SSV which substantially contributes to the filling of visible varicose veins
  • Current or previous Deep Vein Thrombosis
  • Leg obesity
  • Peripheral arterial disease in the leg to be treated
  • Reduced mobility
  • Planned prolonged travel with limited mobility with in 4 weeks of treatment
  • History of pulmonary embolism or stroke
  • Major surgery, prolonged hospitalization or pregnancy within 3 months
  • Current anticoagulation therapy (within 7 days of enrollment)
  • Participation in a clinical study involving a investigational product within 3 months
  • Major co-existing disease or clinically significant laboratory abnormalities
  • Known allergic response to polidocanol or heparin or severe and/or multiple allergic reactions
  • Women of childbearing potential not using effective contraception one month prior to enrollment and/or unwilling to continue while on study
  • Pregnant or lactating women
  • Current alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Scottsdale, Arizona, 85255, United States

Location

Unknown Facility

New York, New York, 10016, United States

Location

Unknown Facility

Charlotte, North Carolina, 28207, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27157, United States

Location

Unknown Facility

Bellevue, Washington, 98004, United States

Location

Related Publications (1)

  • Gibson K, Kabnick L; Varithena(R) 013 Investigator Group. A multicenter, randomized, placebo-controlled study to evaluate the efficacy and safety of Varithena(R) (polidocanol endovenous microfoam 1%) for symptomatic, visible varicose veins with saphenofemoral junction incompetence. Phlebology. 2017 Apr;32(3):185-193. doi: 10.1177/0268355516635386. Epub 2016 Jul 9.

    PMID: 27013511DERIVED

Related Links

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
David Wright MBBS
Organization
BTG International Inc.
david.wright@btgplc.com
610-943-3538

Study Officials

  • Janet Rush, MD

    BTG International Inc.

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2008

First Posted

September 25, 2008

Study Start

October 1, 2008

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

April 21, 2021

Results First Posted

March 24, 2014

Record last verified: 2021-04

Locations

US(5)