Chronic Venous Insufficiency (CVI) CEAP Class C3 or C4 MedDRA version: 14.1 Level: LLT Classification code 10066682 Term: Chronic venous insufficiency System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Doxium 500 mg
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: CALCIUM DOBESILATE
CAS Number: 20123-80-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration
Sponsors
OM PHARMA SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patient • Age 18 to 70 years • Suffering from unilateral or bilateral CVI CEAP Classes C3 or C4 both at screening (V1) and baseline (V2) visits, assessed by clinical examination (V1 and V2) and duplex sonography (within one month before V1) • Presence of pitting oedema and at least one of the following two clinical symptoms, discomfort or pain, in at least one leg at both screening and baseline visits • Chronic oedema at a stable stage • Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range ;Inclusion criteria: • Male or female patient • Age 18 to 70 years • Suffering from unilateral or bilateral CVI CEAP Classes C3 or C4 both at screening (V1) and baseline (V2) visits, assessed by clinical examination (V1 and V2) and duplex sonography (within one month before V1) • Presence of pitting oedema and at least one of the following two clinical symptoms, discomfort or pain, in at least one leg at both screening and baseline visits • Chronic oedema at a stable stage • Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Diseases/symptoms that imitate the symptomatology of CVI (i. e. cardiac, hepatic, renal, orthopaedic, or other causes of leg oedema) • Manifest cardiac insufficiency (Stage NYHA III or IV) • Diabetes mellitus (Type I or II) • Hypertension requiring a change in antihypertensive treatment within 6 weeks before study starts • Operations of the venous system, sclerotherapy during the last 6 months • Compression therapy within the last 6 weeks • Phlebitis or deep leg vein thrombosis in the 3 months preceding inclusion in the study • Any chronic disease which may impair the patient’s ability to participate in the study (i. e. severe congestive heart failure, active gastric or duodenal ulcer, etc.) • Asymptomatic and/or symptomatic peripheral occlusive arterial disease (Ankle/Brachial Index 40 kg/m2) • Diseases of the gastrointestinal tract, which would impair absorption of the study medication • Competing/interfering systemic or local drug treatments (no new medication with a vascular or cardiovascular effect may be taken /administered during the treatment period) • Participation in another clinical trial and/or treatment with an experimental drug within one month before study start • Patients with a known allergy or previous intolerance and/or known hypersensitivity to the study medication • Markedly irregular menstrual cycle (less than 24 or more than 34 days) • Female patients who are pregnant, lactating or of childbearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD) (Pearl-Index 150 µmol/L • Severe hepatic insufficiency, elevated transaminases, i. e. ALAT and ASAT > twice the upper limit of normal • Significant neutropenia, i. e. WBC 10 G/L • Hypoalbuminaemia 40 kg/m2) • Diseases of the gastrointestinal tract, which would impair absorption of the study medication • Competing/interfering systemic or local drug treatments (no new medication with a vascular or cardiovascular effect may be taken /administered during the treatment period) • Participation in another clinical trial and/or treatment with an experimental drug within one month before study start • Patients with a known allergy or previous intolerance and/or known hypersensitivity to the study medication • Markedly irregular menstrual cycle (less than 24 or more than 34 days) • Female patients who are pregnant, lactating or of childbearing potential and not protected from pregnancy by a sufficiently reliable method (OCs, IUD) (Pearl-Index 150 µmol/L • Severe hepatic insufficiency, elevated transaminases, i. e. ALAT and ASAT > twice the upper limit of normal • Significant neutropenia, i. e. WBC 10 G/L • Hypoalbuminaemia < 35 g/L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show the superiority of Doxium® 500 versus placebo in the reduction of oedema of the lower limbs in patients suffering from CVI CEAP Class C3 or C4;Secondary Objective: • Efficacy variables: circumferences of the calf and the ankle, quality of life (questionnaire CIVIQ), symptoms (pain, discomfort, heavy and tired legs, tingling, itching and cramps), efficacy evaluation by both the investigator and the patient •Safety aspects and tolerability of the trial medication ;Primary end point(s): The primary endpoint will be the relative volume change in the most pathological leg using water displacement volumetry.;Main Objective: To show the superiority of Doxium® 500 versus placebo in the reduction of oedema of the lower limbs in patients suffering from CVI CEAP Class C3 or C4;Secondary Objective: • Efficacy variables: circumferences of the calf and the ankle, quality of life (questionnaire CIVIQ), symptoms (pain, discomfort, heavy and tired legs, tingling, itching and cramps), efficacy evaluation by both the investigator and the patient •Safety aspects and tolerability of the trial medication ;Primary end point(s): The primary endpoint will be the relative volume change in the most pathological leg using water displacement volumetry. | — |
Countries
Germany, Italy, Poland, Portugal
Contacts
Public Contact; ;
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Outcome results
None listed