Efficacy and Safety of Coumarin and Troxerutin in the Symptomatic Treatment of Chronic Venous Insufficiency
|Chronic Venous Insufficiency||Drug: Coumarin/troxerutin Drug: Placebo||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluation of Efficacy and Safety of the Fixed-dose Combination of Coumarin and Troxerutin (Venalot®) Versus Placebo in the Symptomatic Treatment of Chronic Venous Insufficiency - VENACT|
- Mean Change (Reduction) From Baseline in Volume of Reference Leg at Week 16 [ Time Frame: Baseline and Week 16 ]Change in the partial volume of legs will be measured using a water plethysmometer. The volume of water (at 34 ± 0.2 °C) displaced after limb immersion is collected in an empty plastic Beaker which has been previously weighed (scale tare). The equilibrium/stability will be estimated using the absolute difference between measures of volume obtained at the Week 16 visit and Baseline to determine the reduction in edema.
- Change (Reduction) From Baseline in Local Complaint Severity [ Time Frame: Baseline and Week 16 ]
Local Complaint Severity will be assessed using the Severity Score of Local Complaints that comprises 8 items: 1=tired legs, 2=heavy legs, 3= feeling of tension, 4=feeling of swelling, 5=aching legs, 6=tingling, 7=itching, 8=burning of soles of the feet.
Each item is classified with a Likert-type scale of 5 levels, where 0=absent, 1=low, 2=medium, 3=high, 4=very high.
A total score is calculated from the sum of the scores of all the 8 items and ranges from 0 (complaints absent) to 32 (very high severity).
- Overall Assessment by the Investigator [ Time Frame: Baseline and Week 16 ]The investigator recorded their impression of the overall clinical picture at the end of the treatment period (Week 16), taking into account the clinical picture compared with the Baseline visit. Data is reported for the percentage of participants in each of the following assessment categories: worsening, unchanged, discreet improvement or accentuated improvement.
- Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline to Week 16 ]Adverse events are any unwanted medical occurrences in an individual taking part in a clinical study who is receiving a pharmaceutical product. The adverse event does not have necessarily a causal relationship with the treatment. In this definition, any adverse or unwanted signals and symptoms, or findings that appear from the start or that deteriorate during the clinical study are also included, i.e. any intercurrent diseases (recently diagnosed concomitant diseases or symptoms), accidents and clinically relevant changes in clinical laboratory values.
|Study Start Date:||May 2013|
|Study Completion Date:||September 2015|
|Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Experimental: Coumarin 30 mg + Troxerutin 180 mg
Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
Coumarin + troxerutin fixed-dose combination tablets
Other Name: Venalot®
Placebo Comparator: Placebo
Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
Coumarin + troxerutin placebo-matching tablets
The drug being tested in this study is the fixed-dose combination of coumarin and troxerutin called Venalot®. Venalot is being tested to treat the symptoms of chronic venous insufficiency. This study will look at symptom relief in people who take Venalot®.
The study will enroll approximately 808 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
- Combination coumarin + troxerutin extended release tablets
- Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.
All participants will be asked to take two tablets three times a day throughout the study.
This multi-centre trial will be conducted in Brazil. The overall time to participate in this study is up to 18 weeks. Participants will make 6 visits to the clinic.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01848210
|Study Director:||Medical Director||Takeda|