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Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

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ClinicalTrials.gov Identifier: NCT03470337
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Thrombophlebitis Leg Drug: Phlogenzym Other: Placebo 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.

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Study Type : Interventional  (Clinical Trial)
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 : September 1996
Actual Primary Completion Date : June 1997
Actual Study Completion Date : June 1997

Arm Intervention/treatment
Experimental: Phlogenzym
Treatment with German licensed drug Phlogenzym (6 tablets/day)
Drug: Phlogenzym
Bromelain / Trypsin / Rutoside
Other Name: Wobenzym plus

Placebo Comparator: Placebo
Placebo equates Phlogenzym but without active ingredients
Other: Placebo



Primary Outcome Measures :
  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 Outcome Measures:
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03470337


Locations
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Italy
Dr. Baumueller
Fano, Italy, 61032
Sponsors and Collaborators
Mucos Pharma GmbH & Co. KG
Investigators
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Principal Investigator: Marcel Baumueller, MD Private Practice
Study Director: Gerhard Stauder, Dr Mucos Pharma GmbH & Co. KG (EX)

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Responsible Party: Mucos Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT03470337     History of Changes
Other Study ID Numbers: MU-696414
First Posted: March 19, 2018    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Thrombophlebitis
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Phlebitis
Peripheral Vascular Diseases
Vasculitis