Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

Phase 3

Completed

• Conditions: Thrombophlebitis Leg
• Interventions: Drug: Phlogenzym; Other: Placebo

• Registration Number: NCT03470337
• Lead Sponsor: Mucos Pharma GmbH & Co. KG

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.

Study Timeline

• Study Start: 1996-09
• Primary Completion: 1997-06
• Study Completion: 1997-06
• Status Verified: 2018-03
• Study First Submitted: 2018-03-06
• Study First Submitted QC: 2018-03-12
• Last Update Submitted: 2018-03-12
• Study First Posted: 2018-03-19
• Last Update Posted: 2018-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phlogenzym	Phlogenzym	Treatment with German licensed drug Phlogenzym (6 tablets/day)
Placebo	Placebo	Placebo equates Phlogenzym but without active ingredients

Primary Outcome Measures

Name	Time	Method
Difference of pain at rest between values day 0 (baseline) and day 7	Change day 0 until day 7	Patients were asked to evaluate resting pain on day 0 (baseline) as well as day 7 on a 10-cm VAS (Visual Analogue Scale), with the left end (0 cm) indicating "no pain" and the right end (10 cm) "unbearable pain". The distance from the left end was recorded.
Responders	day 14	Number of responders (pain value smaller or equal to 1 cm on visual analogue scale for pain (VAS, eft end (0 cm) indicating "no pain" and the right end (10 cm) "unbearable pain") on day 14

Trial Locations

Locations (1)

Dr. Baumueller; 🇮🇹 Fano, Italy