An interventional study of Wobenzym® and Placebo in Osteoarthritis, sponsored by Mucos Pharma GmbH & Co. KG. Completed at 5 sites in Belgium. Open to participants aged 40 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-11-22.
Sponsored by Mucos Pharma GmbH & Co. KG · Not applicable, Interventional, and Treatment
The purpose of this study is to evaluate the pharmacodynamic profile of an oral enzyme treatment with Bromelain, Trypsin and Rutoside in subjects with osteoarthritis.
This study is a randomised, placebo controlled, two parallel arms, cross over, and multicentric trial in 40 male and female subjects suffering from osteoarthritis. While is it well established that Wobenzyme is safe and have proven efficacy in painful conditions, inflammation and osteoarthritis, little is known about its clear mechanism of action underlying its clinical efficacy. This study hypothesises that oral enzyme combination therapy with Wobenzyme will lead to systemic pharmacodynamic effects which will be documented by a holistic assessment of the inflammasome, innate immune system, cartilage turnover, systemic inflammatory markers, as well as potential cellular pathways.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Mucos Pharma GmbH & Co. KG is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Uni- or bilateral femorotibial knee OA :
Exclusion Criteria:
Related to knee:
Knee swelling requiring local injection.
Related to treatments:
to the product :
Treatment with anticoagulants and/or anti- agents
Related to associated diseases:
Severe alteration of mobility enabling functional evaluation.
Related to subjects
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Medicinal product Wobenzym® containing Bromelain (67.5-76.5 mg) adjusted to 450 FIP units, Trypsin (32-48mg) adjusted to 24 µkat and Rutoside trihydrate (100mg).
Drug: Wobenzym®
No active ingredients. The active ingredients will be substituted by microcrystalline cellulose.
Other: Placebo
Wobenzym®
Microcrystalline cellulose
Effects on cartilage biomarkers
Change in sera biomarkers sColl2-1, sColl2-1NO2, sCOMP, sPIIANP and urine biomarker uCTXII between visit 0 and visit 5 measured using immunoassays (Enzyme-linked Immunosorbent assay, ELISA)
Time frame: 20 weeks
Effects on markers of innate immune response
Change in the expression of M1/M2 Polarization specific membrane markers on fresh blood macrophage, between visit 0 and visit 5 using flow cytometry
Time frame: 20 weeks
Effects on systemic inflammatory markers
Change in sera biomarkers NLRP 3 Inflammasome, α-2-macroglobulin, IL-1β, TNFα, IL-6, IL-10, IL-4 between visit 0 and visit 5 measured using immunoassays (Enzyme-linked Immunosorbent assay, ELISA)
Time frame: 20 weeks
Effects on cellular pathways
Change in plasma proteomic profile using liquid chromatography-tandem mass spectrometry (LC-MS/MS) between visit 0 and visit 5.
Time frame: 20 weeks
Vital signs and anthropomorphic measurements
Changes in systolic and diastolic Blood pressure (BP) in mmHg between visit -1 and visit 6
Time frame: 40 weeks
Vital signs and anthropomorphic measurements
Changes in Heart Rate (HR) measured in beats per minute between visit -1 and visit 6
Time frame: 40 weeks
Vital signs and anthropomorphic measurements
Changes in Temperature measured in degrees Celsius between visit -1 and visit 6
Time frame: 40 weeks
Vital signs and anthropomorphic measurements
Changes in weight measured in kilograms, height measured in centimeters and BMI (weight and height will be combined to calculate BMI in kg/m2 between visit -1 and visit 6
Time frame: 40 weeks
Knee Pain
Changes in knee pain at rest and while walking using a Visual Analogue Scale (1 to 100 mm scale where a higher score indicates greater pain intensity) between visit 0 and visit 6
Time frame: 36 weeks
Knee Function
Changes in knee function using Knee injury and Osteoarthristis Outcome Score (KOOS). KOOS is a self-administrated questionnaire comprising 5 subscales: pains, symptoms, activities of daily living, sports and recreation function, and quality of life (0 to 100 scale where 100 indicates the best result) between visit 0 and visit 6
Time frame: 36 weeks
Patient global assessment of disease activity (PGADA)
Changes in PGADA using a Visual Analogue Scale (1 to 100 mm scale where a higher score indicates a higher level of disease activity /a worse global health) between visit 0 and visit 6
Time frame: 36 weeks
Patient physical activity
Effects on subject mobility using a connected device to record heart rate (beats/min between visit 0 and visit 6
Time frame: 36 weeks
Patient physical activity
Effects on subject mobility using a connected device to record number of steps/day taken between visit 0 and visit 6
Time frame: 36 weeks
Patient physical activity
Effects on subject mobility using a connected device to record number of climbed stairs/day between visit 0 and visit 6
Time frame: 36 weeks
Patient physical activity
Effects on subject mobility using a connected device to record intensive exercise minutes/day between visit 0 and visit 6
Time frame: 36 weeks
Patient physical activity
Effects on subject mobility using a connected device to record calories burned/day between visit 0 and visit 6minutes/day between visit 0 and visit 6
Time frame: 36 weeks
Body metabolism
Effects on body metabolism marker TGF-β1, TGF β 2, TGF-β 3 using immunoassays (Enzyme-linked Immunosorbent assay, ELISA) between visit 0 and visit 5
Time frame: 20 weeks
Clinical chemistry
Number of participants with changes in clinical chemistry measurements (concentration of myostatin, hemoglobin, hematocrit, erythrocyte count, TG, TC, LDL, HDL, glucose, hsCRP, uric acid, coagulation markers and key hepatic enzymes) using immunoassays between visit 0 and visit 5
Time frame: 20 weeks
Joint structure modification
Effects on joint structure using either MRI Osteoarthritis Knee Score (MOAKS - a semi quantitative scoring tool. Fourteen subregions are defined for scoring of articular cartilage and bone marrow lesions from grade 0 to grade 3. The more the grade increases, the more important the pathology) or Whole-Organ Magnetic Resonance Imaging Score (WORMS - a semi quantitative scoring tool that examines a spectrum of OA-related structural abnormalities including soft tissue, cartilage and bone in the knee at various anatomical subregion locations. The more the score increases, the more important the pathology) between visit 0 and visit 6
Time frame: 36 weeks
Volume of joint effusion
Volume of joint effusion by MRI using volumetric segmentation method between visit 0 and visit 6
Time frame: 36 weeks
Tolerance
Number of patients with Adverse Events, type of reported adverse events and subject drop out between visit -1 and visit 6
Time frame: 40 weeks
Compliance
Tablet count of investigational product between visit 0 and visit 6
Time frame: 36 weeks
Responder rate to treatment
Responder rate to treatment defined as changes in knee pain and/or knee function and/or patients disease activity using Pain and/or PGADA and/or KOOS according to recommendations of OMERACT OARSI (Osteoarthritis Research Society International (OARSI) Standing Committee for Clinical Trials Response Criteria Initiative and the Outcome Measures in Rheumatology (OMERACT), defined by either a high improvement in pain or in function \>50% and absolute change \>20 or an improvement in at least 2 of the 3 following: pain \>20% and absolute change \>10, function \>20% and absolute change \>10, patient's global assessment \>20% and absolute change \>10 (between visit 0 and visit 6
Time frame: 36 weeks
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Wobenzym
Mucos Pharma GmbH & Co. KG