Study of the mechanism of action of a medicinal product based on Bromelain, Trypsin and Rutoside, compared to the same medicinal product without active ingredient called Placebo in subjects suffering from osteoarthritis.

Phase 1

• Conditions: Subjects suffering from knee Osteoarthitis; MedDRA version: 20.0Level: PTClassification code 10031161Term: OsteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2020-003154-80-BE
• Lead Sponsor: Mucos Pharma GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-07
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Subjects must fulfill all of the following inclusion criteria to be eligible for participation in the study:
1. Male or female = 40 years of age and with BMI = 35 kg/m2;
2. Uni- or bilateral femorotibial knee OA :
a. Responding to clinical and radiological criteria of American College of Rheumatology (ACR);
b. Symptomatic for more than 6 months in the index knee;
c. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Subjects that meet AT LEAST one of the following criteria will be excluded:

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 :
a. severe hepatic and renal impairment;
b. congenital or acquired coagulation disorders, e.g. haemophilia;
c. severe liver and/or kidney damage;
d. hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption;
13. Hypersensitivity or allergy to the product components or 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, except patients on 100 mg low dose Aspirin that have no identifiable risk of bleeding in their medical history upon discretion of the PI.

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 3 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified