CompletedPhase 3

Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance

Italy100 participantsStarted 1996-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Change day 0 until day 7

Responders

Timeframe: day 14

Trial details

NCT IDNCT03470337

SponsorMucos Pharma GmbH & Co. KG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion1997-06

View on ClinicalTrials.gov More Thrombophlebitis Leg trials