Study to Investigate the Mechanism of Action of an Oral Enzyme Treatment With Bromelain, Trypsin and Rutoside Versus Placebo in Subjects With OsTeoarthritis

• Status: Recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mucos Pharma GmbH & Co. KG
• Collaborators: Artialis; Nestlé
• Treatments: Wobenzym

Criteria

Inclusion Criteria:

1. Male or female ≥ 40 years of age and with BMI ≤ 35 kg/m2;

2. Uni- or bilateral femorotibial knee OA :

1. Responding to clinical and radiological criteria of American College of Rheumatology (ACR);

2. Symptomatic for more than 6 months in the index knee;

3. Radiological Kellgren & Lawrence (K&L) grade II-III in standing x-rays from less than 12 months.

3. Mild-to-Moderate mean knee pain score at rest or at walking over the last 24 hours on the index knee evaluated on VAS (0-100) ≥ 40 at baseline;

4. Able to follow the instructions of the study;

5. Having signed an informed consent.

Exclusion Criteria:

Related to knee:

1. Recent macro-trauma of the knee responsible of the symptomatic knee left to the Investigator's discretion;

2. Concurrent articular disease interfering with the evaluation of pain left to the Investigator's discretion;

3. Prosthesis in the target knee;

4. Knee swelling requiring corticosteroids local injection.

Related to treatments:

5. Analgesics to manage knee pain 24 hours before inclusion visit;

6. Corticosteroids injection in the target knee in the last 3 months;

7. Hyaluronan injection in the target knee in the last 6 months;

8. Arthroscopy in the last 6 months;

9. Oral corticotherapy ≥ 5mg/day (in Prednisolone equivalent) in the last 3 months;

10. Symptomatic slow-acting drugs for osteoarthritis (SYSADOA) or dietary supplement, i.e., curcuma extract, chondroitin, glucosamine, diacerein or avocado-soya unsaponifiables in the last 3 months;

11. An anticipated need for any forbidden treatments during the trial;

12. Contraindications to the product :

1. severe hepatic and renal impairment

2. congenital or acquired coagulation disorders, e.g. haemophilia

3. severe liver and/or kidney damage

4. hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

13. Hypersensitivity or allergy to the product components, and pineapple;

14. Treatments based on strontium ranelate, bisphosphonates, selective estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months;

15. Treatment based on zoledronate in the last 2 years;

16. Treatment based on denosumab in the last 6 months;

17. Treatment with anticoagulants and/or anti-platelet agents

Related to associated diseases:

18. Any severe, uncontrolled and limiting disease left to the Investigator's discretion;

19. Patient with widespread pain/depression (e.g. fibromyalgia);

20. Lower or upper extremity surgery or fracture in the last 6 months;

21. Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee;

22. Severe alteration of mobility enabling functional evaluation.

Related to subjects

23. Close collaborators to the investigational team, the study coordinator (ARTIALIS) or to the Sponsor;

24. Currently participating or having participated in another therapeutic clinical trial in the three previous months;

25. Having made a blood donation in the past month;

26. Under guardianship or judicial protection;

27. Pregnancy, breastfeeding, planned conception, or premenopausal women without effective contraception (tablet, patch, ring, diaphragm, implant and intrauterine device, tubal ligation or hysterectomy);

28. Counter-indication to an MRI examination.