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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014