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| Name | Class |
|---|---|
| Statistika Consultoria Ltda | INDUSTRY |
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The purpose of this study is to assess the therapeutic efficacy and safety of Venocur Triplex®, administered BID for 60 days in patients with Chronic Venous Insufficiency rated between CEAP 2 and 4, in comparison to a Placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | Arm treated with Investigational product. |
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| B | Placebo Comparator | Arm treated with placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venocur Triplex® | Drug | Administered by oral route, two coated tablets per day, after the meals (breakfast and dinner), with some liquid, but not with alcoholic beverages. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of the score of the CVI symptoms, based on symptoms as leg pains, cramps, fatigue, aching legs, heavy legs sensation, heat or burning sensation and paresthesia (tingling/numbness) | 60 days | |
| Improvement of each CVI symptoms - leg pains, cramps, fatigue, aching legs, heavy legs sensation, heat or burning sensation and paresthesia (tingling/numbness); | ||
| Safety Assessment through the adverse events reports |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of edema in patients rated between CEAP 3 and 4, as compared to the Placebo group | ||
| Effects of the study drug on the patient's quality of life using questionnaires SF-36 and CVIQ | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belo Horizonte | Minas Gerais | Brazil | ||||
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| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C010619 | phenopyrazone |
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| placebo | Drug | Administered by oral route, two coated tablets per day, after the meals (breakfast and dinner), with some liquid, but not with alcoholic beverages. |
|
| The global clinical improvement of the patient with CVI, using the CGI (Clinical Global Impression) scale. | 60 days |
| Botucatu |
| São Paulo |
| Brazil |
| Marília | São Paulo | Brazil |
| São Paulo | São Paulo | Brazil |