Thrombophlebitis LegPhase 3NCT03470337
Phlogenzym® in Patients With Acute Thrombophlebitis - Efficacy and Tolerance
A Phase 3 study testing Phlogenzym in people with Thrombophlebitis Leg, run by Mucos Pharma GmbH & Co. KG at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombophlebitis Leg
- What is being tested?
- Phlogenzym
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Sep 1996to Jun 1997
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Thrombophlebitis Leg
- Being tested
- Phlogenzym, Placebo
- Keywords
- Thrombophlebitis
- Medical subject headings
- Thrombophlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhlogenzymDrug
Also called Wobenzym plus
Bromelain / Trypsin / Rutoside
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Phlogenzym | Experimental | Treatment with German licensed drug Phlogenzym (6 tablets/day) Receives: Drug: Phlogenzym |
| Placebo | Placebo comparator | Placebo equates Phlogenzym but without active ingredients Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study startSep 1996
- Primary completionJun 1997
- Study completionJun 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombophlebitis LegStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mucos Pharma GmbH & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcel Baumueller, MD, Principal investigator, Private PracticeGerhard Stauder, Dr, Study director, Mucos Pharma GmbH & Co. KG (EX)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470337
- Sponsor's protocol ID
- MU-696414
- Status last verified
- Mar 2018
- First submitted
- 6 Mar 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03470337
- Acronym / sponsor ID
- MU-696414
- Conditions
- Thrombophlebitis Leg
- Keywords
- Thrombophlebitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mucos Pharma GmbH & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Sep 1996
- Primary completion
- Jun 1997 (actual)
- Study completion
- Jun 1997 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phlogenzym | Experimental | Drug: PhlogenzymTreatment with German licensed drug Phlogenzym (6 tablets/day) |
| Placebo | Placebo comparator | Other: PlaceboPlacebo equates Phlogenzym but without active ingredients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- known deep phlebothrombosis
- flourishing ulcus cruris
- arterial occlusive disease
- peripheral neuropathy
- malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhlogenzymAlso: Wobenzym plusBromelain / Trypsin / Rutoside | Drug | Phlogenzym |
| Placebo | Other | Placebo |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel Baumueller, MD principal investigator
Private Practice
Gerhard Stauder, Dr study director
Mucos Pharma GmbH & Co. KG (EX)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phlogenzym in people with Thrombophlebitis Leg, run by Mucos Pharma GmbH & Co. KG at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of pain at rest between values day 0 (baseline) and day 7 (time frame: Change day 0 until day 7). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018; AzTrials last refreshed its copy on 6 Nov 2026.