Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

Thrombophlebitis Leg Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03470337
• Other study ID #: MU-696414
• Status: Completed
• Phase: Phase 3
• First received: March 6, 2018
• Last updated: March 12, 2018
• Start date: September 1996
• Est. completion date: June 1997

Study information

• Verified date: March 2018
• Source: Mucos Pharma GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 1997
• Est. primary completion date: June 1997
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male ?? female patients with thrombophlebitis in the upper extremities (with ?? 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 ?? ? 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 ?? the inactive ingredients of the study medication (especially lactose);

• pregnancy

• lactation,

• known alcohol or drug abuse

• participation in another clinical study

Related Conditions & MeSH terms

• Thrombophlebitis
• Thrombophlebitis Leg

Intervention

Drug:
• Phlogenzym
Bromelain / Trypsin / Rutoside

Other:
• Placebo

Locations

Country	Name	City	State
Italy	Dr. Baumueller	Fano

Sponsors (1)

Lead Sponsor	Collaborator
Mucos Pharma GmbH & Co. KG

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Symptoms	skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness	0, 4, 7, 14 days
Other	Sum Score of Symptoms	Sum score of all described symptoms (skin redness, hyperthermia, palpable/visible phlebitic cords, heaviness, tenseness)	0, 4, 7, 14 days
Primary	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
Primary	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