Study of Antiinflammatory Effects of Detralex (Daflon)
Tracking Information | |||||
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First Received Date ICMJE | July 24, 2012 | ||||
Last Updated Date | August 20, 2012 | ||||
Start Date ICMJE | August 2012 | ||||
Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Antiinflammatory Effects of Detralex (Daflon) [ Time Frame: 14 months ] [ Designated as safety issue: No ] The following markers of inflammation will be analyzed: Blood (biochemical analysis): soluble ICAM-1, soluble VCAM-1, E-selectin, L selectin PAI-1, TIMP-1, Angiopoietin-1, Angiopoietin-2 and Tie-2. Vein wall ([immuno]histological and biochemical analysis) : CD 45 (leukocytes), S100 (C-fibers), MMP3, MMP9, SMC (smooth muscle cells). Presence (or not) of microthrombi in the vein lumen |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT01654016 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Clinical effects of Detralex (Daflon) [ Time Frame: 14 months ] [ Designated as safety issue: Yes ] Subjective perception of pain, leg heaviness, cramping and itching will be assessed using visual analogue scale (VAS) graded from 0 to 10. Leg edema will be assessed by measuring the leg circumference. Data will be recorded as follow:
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study of Antiinflammatory Effects of Detralex (Daflon) | ||||
Official Title ICMJE | Study of Antiinflammatory Effects of Detralex (Daflon) in Patients With Chronic Venous Disease | ||||
Brief Summary | Aim of the study: To investigate if there is a differences in expression of inflammatory markers in venous wall and blood among patients treated with Detralex and those not treated with Detralex (control group). |
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Detailed Description | Chronic venous disease (CVD) represents one of the most common vascular disorder. It's different clinical manifestations (most often seen as varicose veins) can be observed in up to 40% of adult female population and in about 30% of adult males. Different mechanical and biological factors play role in the process of deterioration of venous wall tone and consequent vein valve disfunction that eventually lead to increase venous pressure . Evidence suggest that inflammation has a central place in this process even from the early stage of CVD. Usual symptoms of venous insufficiency are pain, leg heaviness, night cramping, itching, and are often accompanied with leg edema. The extent of clinical manifestation may not correlate with patients' symptoms. Treatment of varicose veins encompasses vein surgery (stripping, phlebectomy, radiofrequency and laser ablation), sclerotherapy and compression therapy. Detralex (in some countries registered as Daflon) is an oral flavonoid that consists of 90% micronized diosmin and 10% flavonoids expressed as hesperidin. Several studies showed some beneficial effects of Detralex in alleviating symptoms in patients with CVD. It may be used in conjunction with surgery, sclerotherapy, or compression therapy or it may be the only therapy when other therapeutical modalities are not indicated or not feasable. Animal studies showed antiinflammatory effects of Daflon in way that Daflon acts favorably on microcirculatory complications by normalizing the synthesis of prostaglandins and free radicals. It decreases bradykinin-induced microvascular leakage and inhibits leukocyte activation, trapping, and migration. However, by searching the available literature (MEDLINE) we found no study that investigated what are the antiinflammatory effects of flavonoids in humans. The aim of this study is to investigate if there is a differences in expression of inflammatory markers in venous wall and blood between patients treated with Detralex and those not treated with Detralex (control group). |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Basic Science |
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Condition ICMJE | Chronic Venous Insufficiency | ||||
Intervention ICMJE | Drug: Detralex
Detralex 500 mg twice daily for three month prior to surgery
Other Name: Daflon |
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Enrolling by invitation | ||||
Estimated Enrollment ICMJE | 84 | ||||
Estimated Completion Date | October 2013 | ||||
Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Croatia | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01654016 | ||||
Other Study ID Numbers ICMJE | Detra-001-Ajd | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Marko Ajduk, MD PhD, University Hospital Dubrava | ||||
Study Sponsor ICMJE | University Hospital Dubrava | ||||
Collaborators ICMJE | Servier | ||||
Investigators ICMJE |
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Information Provided By | University Hospital Dubrava | ||||
Verification Date | August 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |