Safety And Efficacy Study Of Topic Mucopolysaccharide Pol... | NCT01203397

Studies
Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate In The Superficial Varicose Veins Treatment

NCT01203397

Sponsor

EMS

Status

Withdrawn

Last Update Posted

Feb 24, 2021Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

VARICOSE VEINS

Interventions

TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G

Countries

Brazil

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

Feb 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Feb 2015Estimated

First Submitted Date

Sep 15, 2010

First Submission Date that Met QC Criteria

Sep 15, 2010

First Posted Date

Sep 16, 2010Estimated

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

Feb 23, 2021

Last Update Posted Date

Feb 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluate the safety, tolerability and effectiveness of mucopolysaccharide polysulfate in the treatment of superficial varicose veins

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GROUP 2	Active Comparator		Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G
GROUP 1	Experimental		Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G	Drug	APLIED 4 TIMES/DAY AT LESION	GROUP 1 GROUP 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy - Symptoms reduction	The primary outcome measure will be evaluated for: Lesion area reduction, reduction of symptoms time and edema.	Evaluation time: 3 - 7 - 10 and 15 days

Secondary Outcomes

Measure	Description	Time Frame
Efficacy - patient evaluation	The secondary outcome measure will be measured by subjective opinion (daily register.	15 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must be able to understand the study procedures, agree to participate, and give written consent.
Patients must be able to follow the study medication regimen.
Patients with inflammatory process in superficial veins for more than 72 hours.
Presence of symmetric lesions to compare one side to the other.

Exclusion Criteria:

Pregnancy or risk of pregnancy.
Lactation.
Use of topical or systemic anti-inflammatory, antihistamine or immunosuppressive drugs within the last 48 hours prior to the study
Any alteration at other deep veins.
History of atopy or allergic diseases.
History of allergy to any component of the formulations.
Other conditions considered by the investigator as reasonable for non-eligibility.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
FLAVIA ADDOR	Medcin Instituto da Pele	Principal Investigator
Felipe Pinho, MD	EMS	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medcin Instituto Da Pele		Osasco	São Paulo	060323-000	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D014648	Varicose Veins

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided