Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

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)

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.

Study Overview

• Status: Completed
• Conditions: Thrombophlebitis Leg
• Intervention / Treatment: Other: Placebo; Drug: Phlogenzym

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Fano, Italy, 61032
    • Dr. Baumueller

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phlogenzym; Treatment with German licensed drug Phlogenzym (6 tablets/day)	Drug: Phlogenzym; Bromelain / Trypsin / Rutoside; Other Names: Wobenzym plus
Placebo Comparator: Placebo; Placebo equates Phlogenzym but without active ingredients	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of pain at rest between values day 0 (baseline) and 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.	Change day 0 until day 7
Responders	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	day 14

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain under Pressure	Meyer's pressure points at the lateral side of the tibia and Krieger's pressure point in the popliteal space, 4-point rating scale ranging from 0 (no pain) to 3 (severe pain)	0, 4, 7, 14 days
Symptoms	skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness	0, 4, 7, 14 days
Sum Score of Symptoms	Sum score of all described symptoms (skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness)	0, 4, 7, 14 days

Collaborators and Investigators

• Sponsor: Mucos Pharma GmbH & Co. KG
• Investigators: Principal Investigator: Marcel Baumueller, MD, Private Practice; Study Director: Gerhard Stauder, Dr, Mucos Pharma GmbH & Co. KG (EX)

Study record dates

Study Major Dates

• Study Start: September 1, 1996
• Primary Completion (Actual): June 1, 1997
• Study Completion (Actual): June 1, 1997

Study Registration Dates

• First Submitted: March 6, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 12, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Thrombophlebitis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Vasculitis; Venous Thrombosis; Thrombosis; Peripheral Vascular Diseases; Phlebitis; Thrombophlebitis; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Wobenzym
• Other Study ID Numbers: MU-696414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No