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

September 15, 2010
March 1, 2013
September 2014
December 2014   (final data collection date for primary outcome measure)
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.
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 simptoms time and edema.
Complete list of historical versions of study NCT01203397 on ClinicalTrials.gov Archive Site
Efficacy - patient evaluation [ Time Frame: 15 days ] [ Designated as safety issue: No ]
The secondary outcome measure will be measured by subjective opinion (daily register.
Efficacy - patient evaluation [ Time Frame: 15 days ] [ Designated as safety issue: No ]
The secondary outcome measure will be mesured by subjective opinion (daily register.
Not Provided
Not Provided
 
Safety And Efficacy Study Of Topic Mucopolysaccharide Polysulfate In The Superficial Varicose Veins Treatment
PHASE III OF SAFETY AND EFFICACY STUDY OF TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G IN THE SUPERFICIAL VARICOSE VEINS TREATMENT

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
VARICOSE VEINS
Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G
APLIED 4 TIMES/DAY AT LESION
  • Active Comparator: GROUP 2
    Intervention: Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G
  • Experimental: GROUP 1
    Intervention: Drug: TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
70
February 2015
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01203397
MPSEMS0110
Yes
EMS
EMS
Not Provided
Principal Investigator: FLAVIA ADDOR MEDCIN INSTITUTO DA PELE
Study Director: Felipe Pinho, MD EMS
EMS
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP