Clinical trial NCT03470337: Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance
Official title: Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance - Randomised Double-blind Study Phase III With Parallel Groups vs. Placebo According to the Guidelines of Good Clinical Practice (GCP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thrombophlebitis Leg
Keywords: Thrombophlebitis
Lead sponsor: Mucos Pharma GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2018-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 medication and physical treatments. This randomized, double-blinded trial compares efficacy and safety with placebo.

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 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.

Eligibility 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

Primary outcomes:
measure: Difference of pain at rest between values day 0 (baseline) and day 7
timeFrame: Change day 0 until day 7
measure: Responders
timeFrame: day 14
Secondary outcomes:
Other outcomes:
measure: Pain under Pressure
timeFrame: 0, 4, 7, 14 days
measure: Symptoms
timeFrame: 0, 4, 7, 14 days
measure: Sum Score of Symptoms
timeFrame: 0, 4, 7, 14 days
Locations:
city: Fano
country: Italy
facility: Dr. Baumueller
Study officials:
affiliation: Private Practice
name: Marcel Baumueller, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mucos Pharma GmbH & Co. KG (EX)
name: Gerhard Stauder, Dr
role: STUDY_DIRECTOR
References: