Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

Mucos Pharma

Status and phase: Completed; Phase 3

Conditions: Thrombophlebitis Leg

Treatments: Drug: Phlogenzym; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03470337

MU-696414

Details and patient eligibility

About

Oral enzyme therapy in patients with acute superficial vein inflammation (thrombophlebitis) can serve as an additional treatment option besides standard therapy with compression stockings, common pain medication and physical treatments. This randomized, double-blinded trial compares efficacy and safety with placebo.

Full description

Enzymes are absorbed in the small intestine and taken up into the bloodstream, at least to some extent. There, they act in an anti-inflammatory manner, as was first described for the serine protease trypsin. Similarly, the cysteine protease bromelain, extracted from the stems of pineapples, is an effective phytotherapeutical drug with anti-inflammatory properties.Proteases have also been indicated to show a certain improvement of the fluidity of the blood. An additional component of the oral enzyme combination can be rutoside, or rutin, a flavonoid known to have cytoprotective and anti-inflammatory properties.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male ог female patients with thrombophlebitis in the upper extremities (with ог without varicosis);
• age ~ 18 years;
• acute thrombophlebitis in the lower leg
• moderate to severe pain as monitored on a visual analog scale (VAS, value ≥ 3 cm)
• pain under pressure
• presence of at least three of the following symptoms: skin redness, hyperthermia, phlebitic cords, feeling of heaviness and tenseness.

Exclusion criteria

• known deep phlebothrombosis
• flourishing ulcus cruris
• arterial occlusive disease
• peripheral neuropathy
• malignant disease
• concomitant concomitant treatment ог а therapy which ended less than 7 days before baseline with corticosteroids, diuretics, anticoagulative agents, platelet aggregation inhibitors and systemic/topical use of anti-inflammatory agents, other preparations for veins and analgesics;
• known intolerance against the active ог the inactive ingredients of the study medication (especially lactose);
• pregnancy
• lactation,
• known alcohol or drug abuse
• participation in another clinical study

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Phlogenzym

Experimental group

Description:

Treatment with German licensed drug Phlogenzym (6 tablets/day)

Treatment:

Drug: Phlogenzym

Placebo

Placebo Comparator group

Description:

Placebo equates Phlogenzym but without active ingredients

Treatment:

Other: Placebo