EUCTR2020-003154-80-BE进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled, Crossover Study to Investigate the Mechanism of Action of an Oral Enzyme Treatment with Bromelain, Trypsin and Rutoside versus Placebo in Subjects with OsTeoarthritis (WOBE-SMART) - WOBE-SMART study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
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