Status:
COMPLETED
Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance
Lead Sponsor:
Mucos Pharma GmbH & Co. KG
Conditions:
Thrombophlebitis Leg
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed 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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 1996
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 1997
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03470337
Start Date
September 1 1996
End Date
June 1 1997
Last Update
March 19 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Dr. Baumueller
Fano, Italy, 61032