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NCT01203397 Clinical Trial

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

VARICOSE VEINS Clinical Trial

Official title:
PHASE III OF SAFETY AND EFFICACY STUDY OF TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G IN THE SUPERFICIAL VARICOSE VEINS TREATMENT

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01203397
Other study ID # MPSEMS0110
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date September 2014
Est. completion date February 2015

Study information
Verified date February 2021
Source EMS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date February 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G
APLIED 4 TIMES/DAY AT LESION

Locations
Country Name City State
Brazil Medcin Instituto Da Pele Osasco SÃO Paulo

Sponsors (1)
Lead Sponsor Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Efficacy - patient evaluation The secondary outcome measure will be measured by subjective opinion (daily register. 15 days
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