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

This study has suspended participant recruitment.
(Study suspended by decision strategically.)
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01203397
First received: September 15, 2010
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
VARICOSE VEINS
Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PHASE III OF SAFETY AND EFFICACY STUDY OF TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G IN THE SUPERFICIAL VARICOSE VEINS TREATMENT

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Efficacy - Symptoms reduction [ Time Frame: Evaluation time: 3 - 7 - 10 and 15 days ] [ Designated as safety issue: Yes ]
    The primary outcome measure will be evaluated for: Lesion area reduction, reduction of symptoms time and edema.


Secondary Outcome Measures:
  • Efficacy - patient evaluation [ Time Frame: 15 days ] [ Designated as safety issue: No ]
    The secondary outcome measure will be measured by subjective opinion (daily register.


Estimated Enrollment: 70
Study Start Date: September 2014
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GROUP 2 Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G
APLIED 4 TIMES/DAY AT LESION
Experimental: GROUP 1 Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G
APLIED 4 TIMES/DAY AT LESION

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01203397

Locations
Brazil
Medcin Instituto Da Pele
Osasco, São Paulo, Brazil, 060323-000
Sponsors and Collaborators
EMS
Investigators
Principal Investigator: FLAVIA ADDOR MEDCIN INSTITUTO DA PELE
Study Director: Felipe Pinho, MD EMS
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01203397     History of Changes
Other Study ID Numbers: MPSEMS0110
Study First Received: September 15, 2010
Last Updated: March 1, 2013
Health Authority: Brazil: Ministry of Health

Keywords provided by EMS:
SUPERFICIAL VARICOSE VEINS

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014