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

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ClinicalTrials.gov Identifier: NCT01203397
Recruitment Status : Suspended (Study suspended by decision strategically.)
First Posted : September 16, 2010
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
EMS

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

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
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




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


Secondary Outcome Measures :
  1. Efficacy - patient evaluation [ Time Frame: 15 days ]
    The secondary outcome measure will be measured by subjective opinion (daily register.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01203397     History of Changes
Other Study ID Numbers: MPSEMS0110
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013

Keywords provided by EMS:
SUPERFICIAL VARICOSE VEINS

Additional relevant MeSH terms:
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Heparinoids
Anti-Inflammatory Agents
Anticoagulants