The Efficacy and Safety of Different Phlebotonic Drugs in... | NCT05113420

Studies
The Efficacy and Safety of Different Phlebotonic Drugs in Children With Venous Malformations

NCT05113420

Sponsor

Center for Vascular Pathology, Moscow

Status

Unknown status

Last Update Posted

Nov 9, 2021Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Drug Effect
Children, Only
Vascular Malformations
Surgery

Interventions

Detralex
Troxevasin

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 17, 2019Actual

Primary Completion Date

Nov 17, 2021Estimated

Completion Date

Sep 17, 2022Estimated

First Submitted Date

Oct 9, 2021

First Submission Date that Met QC Criteria

Oct 28, 2021

First Posted Date

Nov 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2021

Last Update Posted Date

Nov 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to evaluate the efficacy and safety of different phlebotonic drugs in children and to assess patient satisfaction after treatment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Per os+topical solution(1)			Drug: Detralex
Per os+topical solution(2)			Drug: Detralex Drug: Troxevasin
Per os only			Drug: Detralex
Topical solution only			Drug: Detralex Drug: Troxevasin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Detralex	Drug	Diosmin+ Hesperidin	Per os only Per os+topical solution(1) Per os+topical solution(2) Topical solution only

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Coagulation testing	Coagulation testing	1 month

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Satisfaction after treatment	Questionnaire	1 month

Eligibility Module

Eligibility Criteria

Inclusion Criteria: venous malformation

venous malformation

Exclusion Criteria:

allergy

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ekaterina Listovskaia	Contact	+79032069027		listovskaya_ek@outlook.com

Overall Officials

Name	Affiliation	Role
Ekaterina Listovskaia, MD	Vascular Anomalies Center (VAC) "Hemangioma" LLC.	Study Chair
Dmitriy Romanov, MD	Vascular Anomalies Center (VAC) "Hemangioma" LLC.	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Vascular Anomalies Center (VAC) "Hemangioma" LLC	Recruiting	Moscow		109028	Russia

Condition Browse Module

MeSH Terms

ID	Term
D054079	Vascular Malformations

Ancestor Terms

ID	Term
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C080675	S 5682
C053279	troxevasin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided