NCT01203397

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
withdrawn

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 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2010

Completed
4 years until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

3 months

First QC Date

September 15, 2010

Last Update Submit

February 23, 2021

Conditions

VARICOSE VEINS

Keywords

SUPERFICIAL VARICOSE VEINS

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Efficacy - patient evaluation

    15 days

Study Arms (2)

GROUP 2

ACTIVE COMPARATOR
Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G

GROUP 1

EXPERIMENTAL
Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G

Interventions

TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/GDRUG

APLIED 4 TIMES/DAY AT LESION

GROUP 1GROUP 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medcin Instituto Da Pele

Osasco, São Paulo, 060323-000, Brazil

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • FLAVIA ADDOR

    Medcin Instituto da Pele

    PRINCIPAL INVESTIGATOR

  • Felipe Pinho, MD

    EMS

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 16, 2010

Study Start

September 1, 2014

Primary Completion

December 1, 2014

Study Completion

February 1, 2015

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

BR(1)