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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

BTG International Inc.

ClinicalTrials.gov Identifier:

NCT01231373

First received: October 22, 2010

Last updated: February 19, 2014

Last verified: February 2014

History of Changes

Results First Received: December 20, 2013

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

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	59	58	60	58
COMPLETED	56	57	60	57
NOT COMPLETED	3	1	0	1
Withdrawal by Subject	2	0	0	0
Lost to Follow-up	0	0	0	1
Withdrew consent	1	1	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
Number of Participants [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:

The Absolute Change From Baseline in Patient Symptom Assessment Score (Called VVSymQ). [ Time Frame: 8 weeks ]

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2. Secondary:

Change in Varicose Vein Appearance as Rated by Blinded Central Independent Physician Photography Review [ Time Frame: 8 weeks ]

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Measure Type	Secondary
Measure Title	Change in Varicose Vein Appearance as Rated by Blinded Central Independent Physician Photography Review
Measure Description	The absolute change from baseline in appearance score blinded independent photography review (IPR-V3; physician appearance assessment) at week 8. Panel of 3 blinded physicians reviewed before/after standardized digital photos and provided scores ranging from 0 (no varicose veins visible) to 4 (very severe). Scores were averaged by reviewer. Absolute change in scores from baseline to week 8 were compared between vehicle and each dose.
Time Frame	8 weeks
Safety Issue	No

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 with a baseline and week 8 visit.

Reporting Groups

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

Measured Values

	Vehicle	Polidocanol Injectable Foam, 0.125%	Polidocanol Injectable Foam, 0.5%	Polidocanol Injectable Foam, 1.0%
Number of Participants Analyzed [units: participants]	56	56	60	57
Change in Varicose Vein Appearance as Rated by Blinded Central Independent Physician Photography Review [units: units on a scale] Mean ± Standard Error	-0.07 ± 0.080	-0.74 ± 0.081	-0.89 ± 0.078	-0.83 ± 0.080

Statistical Analysis 1 for Change in Varicose Vein Appearance as Rated by Blinded Central Independent Physician Photography Review

Groups ^[1]	Vehicle vs. Polidocanol Injectable Foam, 0.125%
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001
Mean Difference (Final Values) ^[4]	-0.66
Standard Error of the mean	± 0.081
95% Confidence Interval	( -0.88 to -0.45 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant method information, such as adjustments or degrees of freedom:
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[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4]	Other relevant estimation information:
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Statistical Analysis 2 for Change in Varicose Vein Appearance as Rated by Blinded Central Independent Physician Photography Review

Groups ^[1]	Vehicle vs. Polidocanol Injectable Foam, 0.5%
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001
Mean Difference (Final Values) ^[4]	-0.82
Standard Error of the mean	± 0.078
95% Confidence Interval	( -1.04 to -0.61 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

Statistical Analysis 3 for Change in Varicose Vein Appearance as Rated by Blinded Central Independent Physician Photography Review

Groups ^[1]	Vehicle vs. Polidocanol Injectable Foam, 1.0%
Method ^[2]	ANCOVA
P Value ^[3]	<0.0001
Mean Difference (Final Values) ^[4]	-0.75
95% Confidence Interval	( -0.97 to -0.54 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant method information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.
[4]	Other relevant estimation information:
	No text entered.

3. Secondary:

Absolute Change From Baseline to Week 8 (PA-V3; Patient Assessment of Varicose Vein 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

No publications provided

Responsible Party:	BTG International Inc.
ClinicalTrials.gov Identifier:	NCT01231373 History of Changes
Other Study ID Numbers:	VAP.VV016
Study First Received:	October 22, 2010
Results First Received:	December 20, 2013
Last Updated:	February 19, 2014
Health Authority:	United States: Food and Drug Administration

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