EUCTR2006-006485-42-SE进行中（未招募）不适用
Double-Blind, Randomized, Parallel Group, Multicenter Study of Durolane Compared to Methylprednisolone in Subjects with Osteoarthritis of the Knee
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Q-Med AB
- 入组人数
- 432
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
- •1. Subject (female or male) 35-80 years of age, inclusive;
- •2. Unilateral knee pain fulfilling ACR criteria for diagnosis of OA (see Appendix 2), most days of the month, for three months;
- •3. Radiographic evidence of OA in the study knee (Kellgren-Lawrence radiographic score 2 or 3).40 X-rays obtained within 6 months prior to screening are acceptable;
- •4. WOMAC pain score of 7-17 in the study knee at both the screening and baseline visits;
- •5. Subject normally active, not bedridden or confined to a wheelchair, and able to walk 50 meters without the help of a walker, crutches, or a cane;
- •6. Subject has attempted but not responded adequately to previous non-pharmacological therapy(ies);
- •7. Subject cooperative and able to communicate effectively with the investigators;
- •8. Body mass index (BMI) less than or equal to 40 kg/m2;
- •9. Signed informed consent obtained.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. A clinically detectable knee effusion (positive bulge sign or positive patellar tap);
- •2. Clinically significant contralateral knee OA as evidenced by a WOMAC pain score in this knee >3 (out of 20);
- •3. Clinically significant hip pain defined by the question, Have you suffered from pain in or around the hip in most days in the previous month?”;
- •4. Clinically significant joint pain from joints other than the knee or hip;
- •5. Previous intra-articular steroid injection into the study knee within the last 3 months;
- •6. Previous intra-articular HA injection into the study knee within the last 9 months;
- •7. Previous allergic type reaction to a HA product, a steroid, or lidocaine/related anesthetics;
- •8. Treatment with analgesics other than paracetamol (acetaminophen) (including topical agents for the knee) within 5 half lives of the drug prior to the baseline visit;
- •9. Use of opioids other than weak opioids (codeine up to 15 mg per tablet, propoxyphene, dextropropoxyphene) for OA pain on 3 or more days/week within the last month;
- •10. Use of paracetamol (acetaminophen) or any other analgesic during the 24 hours preceding the baseline visit;
- •11. Use of systemic glucocorticosteroids (excluding inhaled steroids) within the last 3 months;
- •12. Treatment with glucosamine/chondroitin sulfate initiated within the past 3 months, or dosage not stable for the past 3 months;
- •13. Change in physical therapy for the knee within the last three months, or expected change in physical therapy for the knee during the study,;
- •14. Serious injury to the study knee in the previous 6 months;
- •15. Arthroscopy or other surgical procedure in the study knee within the past 12 months;
- •16. Any planned arthroscopy or other surgical procedure during the study period;
- •17. Previous history or presence of active septic arthritis in the study knee;
- •18. Active skin disease or infection in the area of the injection site;
- •19. Systemic active inflammatory condition or infection, such as rheumatoid arthritis, inflammatory arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, gout/ acute pseudogout or any other connective tissue disease;
- •20. Bleeding diathesis or use of anticoagulants (except for acetylsalicylic acid maximum 325 mg/day);
- •21. Current uncontrolled diabetes mellitus;
- •22. Known history of drug or alcohol abuse within 6 months prior to screening;
- •23. Any medical condition that in the opinion of the investigator makes the subject unsuitable for inclusion (e.g., severe progressive chronic disease, malignancy, bleeding disorder, fibromyalgia, significant venous or lymphatic stasis) or that, in the opinion of the investigator, are unsuitable for inclusion (e.g., subjects not likely to avoid other therapies, subjects not likely to stay in the study during the whole study period or likely to be unreliable);
- •24. Pregnant or breastfeeding woman or woman of childbearing potential not practicing adequate contraception;
- •25. Involvement in other clinical trials that involve treatment or any other intervention within the 30 days prior to screening.
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