NCT03470337

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 1996

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1996

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 1997

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1997

Completed
20.8 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
Last Updated

March 19, 2018

Status Verified

March 1, 2018

Enrollment Period

9 months

First QC Date

March 6, 2018

Last Update Submit

March 12, 2018

Conditions

Thrombophlebitis Leg

Keywords

Thrombophlebitis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Other Outcomes (3)

  • Pain under Pressure

    0, 4, 7, 14 days

  • Symptoms

    0, 4, 7, 14 days

  • Sum Score of Symptoms

    0, 4, 7, 14 days

Study Arms (2)

Phlogenzym

EXPERIMENTAL

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

Drug: Phlogenzym

Placebo

PLACEBO COMPARATOR

Placebo equates Phlogenzym but without active ingredients

Other: Placebo

Interventions

PhlogenzymDRUG

Bromelain / Trypsin / Rutoside

Also known as: Wobenzym plus
Phlogenzym
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Baumueller

Fano, 61032, Italy

Location

MeSH Terms

Conditions

Thrombophlebitis

Interventions

PhlogenzymWobenzym

Condition Hierarchy (Ancestors)

Venous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPhlebitisPeripheral Vascular DiseasesVasculitis

Study Officials

  • Marcel Baumueller, MD

    Private Practice

    PRINCIPAL INVESTIGATOR

  • Gerhard Stauder, Dr

    Mucos Pharma GmbH & Co. KG (EX)

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-Blinded
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2018

First Posted

March 19, 2018

Study Start

September 1, 1996

Primary Completion

June 1, 1997

Study Completion

June 1, 1997

Last Updated

March 19, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)