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Completed

NCT Number: NCT03470337

Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. Baumueller

Fano, 61032, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phlogenzym

Drug

Bromelain / Trypsin / Rutoside

Other names: Wobenzym plus

Placebo

Other

Primary outcomes

  1. Difference of pain at rest between values day 0 (baseline) and day 7

    Time frame: 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

    Time frame: 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 outcomes

  1. Pain under Pressure

    Time frame: 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

    Time frame: 0, 4, 7, 14 days

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

  3. Sum Score of Symptoms

    Time frame: 0, 4, 7, 14 days

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

Sponsors and collaborators

Lead sponsor

Mucos Pharma GmbH & Co. KG

Industry

Registry information

Official study 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)

Important dates

Study start
1996
Primary completion
1997
Study completion
1997
First posted
Mar 19, 2018
Registry last updated
Mar 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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