Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

• Status: Completed
• Trial end date: 1997-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mucos Pharma GmbH & Co. KG
• Treatments: Wobenzym

Criteria

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