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Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

Primary Purpose

Thrombophlebitis Leg

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Phlogenzym
Placebo
Sponsored by
Mucos Pharma GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Thrombophlebitis Leg focused on measuring Thrombophlebitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. Baumueller

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Phlogenzym

Placebo

Arm Description

Treatment with German licensed drug Phlogenzym (6 tablets/day)

Placebo equates Phlogenzym but without active ingredients

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
March 6, 2018
Last Updated
March 12, 2018
Sponsor
Mucos Pharma GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT03470337
Brief Title
Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance
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 Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 1996 (undefined)
Primary Completion Date
June 1997 (Actual)
Study Completion Date
June 1997 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mucos Pharma GmbH & Co. KG

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombophlebitis Leg
Keywords
Thrombophlebitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-Blinded
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phlogenzym
Arm Type
Experimental
Arm Description
Treatment with German licensed drug Phlogenzym (6 tablets/day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo equates Phlogenzym but without active ingredients
Intervention Type
Drug
Intervention Name(s)
Phlogenzym
Other Intervention Name(s)
Wobenzym plus
Intervention Description
Bromelain / Trypsin / Rutoside
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Difference of pain at rest between values day 0 (baseline) and day 7
Description
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.
Time Frame
Change day 0 until day 7
Title
Responders
Description
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
Time Frame
day 14
Other Pre-specified Outcome Measures:
Title
Pain under Pressure
Description
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)
Time Frame
0, 4, 7, 14 days
Title
Symptoms
Description
skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness
Time Frame
0, 4, 7, 14 days
Title
Sum Score of Symptoms
Description
Sum score of all described symptoms (skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness)
Time Frame
0, 4, 7, 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcel Baumueller, MD
Organizational Affiliation
Private Practice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerhard Stauder, Dr
Organizational Affiliation
Mucos Pharma GmbH & Co. KG (EX)
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Baumueller
City
Fano
ZIP/Postal Code
61032
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

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