Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence (VANISH-2)

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Varicose Veins
Interventions:	Drug: polidocanol injectable foam, 0.125%; Drug: polidocanol injectable foam, 0.5%; Drug: polidocanol injectable foam, 1.0%; Drug: Vehicle

  Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Three (3) patients were randomized but never treated.

Reporting Groups

	Description
Vehicle	Vehicle: Injection of vehicle comparator
Polidocanol Injectable Foam, 0.125%	active placebo for blinding of therapeutic polidocanol dose
Polidocanol Injectable Foam, 0.5%	lower experimental polidocanol dose
Polidocanol Injectable Foam, 1.0%	1.0% polidocanol foam injection

Participant Flow:   Overall Study

	Vehicle	Polidocanol Injectable Foam, 0.125%	Polidocanol Injectable Foam, 0.5%	Polidocanol Injectable Foam, 1.0%
STARTED	59	58	60	58
Patients Receiving Blinded Treatment	57	57	60	58
COMPLETED	56	57	60	57
NOT COMPLETED	3	1	0	1
Withdrew consent prior to randomization	2	1	0	0
Lost to Follow-up	0	0	0	1
Withdrew Consent	1	0	0	0

  Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients receiving blinded treatment

Reporting Groups

	Description
Vehicle	Vehicle: Injection of vehicle comparator
Polidocanol Injectable Foam, 0.125%	polidocanol injectable foam active placebo
Polidocanol Injectable Foam, 0.5%	polidocanol injectable foam lower experimental dose
Polidocanol Injectable Foam, 1.0%	polidocanol injectable foam therapeutic dose
Total	Total of all reporting groups

Baseline Measures

	Vehicle	Polidocanol Injectable Foam, 0.125%	Polidocanol Injectable Foam, 0.5%	Polidocanol Injectable Foam, 1.0%	Total
Overall Participants Analyzed; [Units: Participants]	57	57	60	58	232
Age; [Units: Years]; Mean (Standard Deviation)	49.8 (10.44)	52.8 (10.06)	50.4 (9.89)	50.4 (11.42)	50.8 (10.47)
Gender; [Units: Participants]
Female	42	43	40	44	169
Male	15	14	20	14	63
Race/Ethnicity, Customized; [Units: Participants]
White	54	53	55	53	215
Black	2	1	3	0	6
Asian	0	1	0	1	2
American Indian/Eskimo	0	0	0	1	1
Other	1	2	2	3	8
Weight; [Units: Kilograms]; Mean (Standard Deviation)	83.0 (20.22)	85.3 (16.41)	88.8 (22.66)	81.4 (20.22)	84.8 (20.11)
Height; [Units: Centimeters]; Mean (Standard Deviation)	169.7 (9.45)	168.6 (9.38)	169.6 (10.47)	169.1 (9.27)	169.3 (9.61)
Calculated BMI; [Units: Kg/m^2]; Mean (Standard Deviation)	28.8 (5.76)	30.1 (19.48)	30.7 (6.28)	28.4 (6.45)	29.5 (6.03)

  Outcome Measures

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1. Primary:

Change in Patient-Reported Symptoms of Varicose Veins (VVSymQ Score) [ Time Frame: 8 weeks ]

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2. Secondary:

Change From Baseline to 8 Weeks in Appearance as Rated by Patient (PA-V3) [ Time Frame: 8 weeks ]

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3. Secondary:

Change From Baseline at 8 Weeks Post-Treatment in IPR-V3 Score--Physician Photographic Review of Appearance [ Time Frame: 8 weeks ]

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  Serious Adverse Events

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  Other Adverse Events

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  Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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Certain Agreements:  

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is: The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo. The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Results Point of Contact:  

Name/Title: David Wright MBBS
Organization: BTG International Inc.
phone: 610-278-1660
e-mail: david.wright@btgplc.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Todd KL 3rd, Wright DI; VANISH-2 Investigator Group. Durability of treatment effect with polidocanol endovenous microfoam on varicose vein symptoms and appearance (VANISH-2). J Vasc Surg Venous Lymphat Disord. 2015 Jul;3(3):258-264.e1. doi: 10.1016/j.jvsv.2015.03.003. Epub 2015 May 6.

Responsible Party:	BTG International Inc.
ClinicalTrials.gov Identifier:	NCT01231373 History of Changes
Other Study ID Numbers:	VAP.VV016
First Submitted:	October 22, 2010
First Posted:	November 1, 2010
Results First Submitted:	December 20, 2013
Results First Posted:	April 2, 2014
Last Update Posted:	March 12, 2015