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Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

Sponsor
Mucos Pharma GmbH & Co. KG (Industry)
Overall Status
Completed
CT.gov ID
NCT03470337
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
9
Duration (Months)
11.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-Blinded
Primary Purpose:
Supportive Care
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 Start Date :
Sep 1, 1996
Actual Primary Completion Date :
Jun 1, 1997
Actual Study Completion Date :
Jun 1, 1997

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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

    Other Outcome Measures

    1. Pain under Pressure [0, 4, 7, 14 days]

      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)

    2. Symptoms [0, 4, 7, 14 days]

      skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness

    3. Sum Score of Symptoms [0, 4, 7, 14 days]

      Sum score of all described symptoms (skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dr. Baumueller Fano Italy 61032

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mucos Pharma GmbH & Co. KG
    ClinicalTrials.gov Identifier:
    NCT03470337
    Other Study ID Numbers:
    • MU-696414
    First Posted:
    Mar 19, 2018
    Last Update Posted:
    Mar 19, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mucos Pharma GmbH & Co. KG
    Thrombophlebitis
    Additional relevant MeSH terms:
    Thrombophlebitis
    Wobenzym

    Study Results

    No Results Posted as of Mar 19, 2018