EUCTR2014-001076-58-DK进行中（未招募）1 期
BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
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
- 160
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. Male or female, 40 to 75 years of age on the day of randomization (day 1).
- •2. Written informed consent has been obtained.
- •3. Written documentation has been obtained prior to initiating any study specific procedures in accordance with the relevant country and local privacy requirements, where applicable (e.g. Written Authorization for Use and Release of Health and Research Study Information (US sites) and written Data Protection consent (EU sites).
- •4. Diagnosis of primary idiopathic OA in the study knee in accordance with the American College of Rheumatology (ACR) modified clinical classification criteria for = 52 weeks prior to visit 1.
- •5. Kellgren-Lawrence grade II or III as confirmed by x-ray obtained at visit 1 or = 12 weeks prior to visit 1.
- •6. Washout of all prohibited acute and chronic pain medications (eg, anti-inflammatory drugs and analgesics) other than protocol permitted rescue treatment or other medications/treatments allowed per protocol is
- •completed at least 2 days prior to visit 2.
- •7. The average daily pain score over the first 7 days after initiation of the baseline period must be 4.0 to 9.0. This score is specific for the study knee as derived from daily pain scores recorded by the subject in the e-diary.
- •8. No evidence of abnormal mechanical symptoms such as locking or catching of the study knee per medical history or physical examination.
- •9. If a subject has bilateral knee OA, the subject must be able to distinguish which knee is the predominant source of pain. This knee must be designated as the study knee.
- •10. Body weight = 60 kg and = 150 kg inclusive.
- •11. For females of childbearing potential, a negative urine pregnancy test at visits 1, 2, and 3 (prior to the administration of the study medication) is required.
- •12. Must be ambulatory without assistive walking devices, able to perform usual daily activities, and agree to maintain the similar activity level throughout the course of the study.
- •13. Subject’s global assessment of knee OA is ‘fair’, ‘poor’, or ‘very poor’ at visit 2.
- •14. Ability to follow study instructions, likely to comply with the daily e-diary recording, and likely to complete all required visits.
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1. Concurrent chronic pain conditions, or peripheral or central neuropathy that may affect sensation of the study knee area, including but not limited to back pain, hip pain, disc herniation, peripheral nerve entrapment, diabetic neuropathy, post-stroke pain, or fibromyalgia.
- •2. painDETECT Questionnaire score = 13 at visit 2.
- •3. Subject diagnosed with any condition suggestive of a secondary cause of knee OA including but not limited to knee trauma, articular fracture, major dysplasias or congenital abnormality, acromegaly, ochronosis, hemochromatosis, Wilson’s disease, or primary osteochondromatosis.
- •4. History of or current evidence of rheumatoid arthritis as diagnosed by American College of Rheumatology (ACR) criteria.
- •5. Presence of bursitis, or tear of meniscus or ligament of the study knee, or history of significant injury or surgery to the study knee = 52 weeks prior to visit 1.
- •6. Surgery of the study knee, such as, arthroplasty, arthroscopy inspection, or repair of knee ligaments that is planned to occur during the study period.
- •7. Treatment with IA hyaluronic acid in the study knee = 24 weeks prior to visit 1.
- •8. Treatment with IA corticosteroid in the study knee = 12 weeks prior to visit 1.
- •9. History or current diagnosis of gout or pseudogout with any joint involvement.
- •10. History or current diagnosis of Reiter’s, Sjögren’s syndrome, psoriasis or systemic lupus erythematosus or other autoimmune diseases with any joint involvement.
- •11. Evidence of skin infection or joint infection of the study knee.
- •12. Evidence of abnormal coagulation status (eg, excessive tooth bleeding with brushing) or subjects with hemophilia or other blood diseases affecting coagulation (eg, aplastic anemia, leukemia), or under chemo-/radio-therapy.
- •13. Use of prohibited medications or treatments for at least 2 days prior to initiating the baseline period or during the baseline period (which starts at visit 2 and ends at day -1)
- •14. Subject has initiated or changed their established physiotherapy or occupational therapy program that is specific to the lower extremities = 14 days prior to visit 3.
- •15. Subjects using concomitant transcutaneous electrical nerve stimulation (TENS) or acupuncture to either lower extremity = 14 days prior to visit 3.
- •16. Subject does not record a minimum of 5 days’ worth of e-diary data for the first 7 days after initiation of the baseline period at visit 2.
- •17. History of severe, progressive, or current unstable medical conditions other than OA.
- •18. Subjects with an active malignancy of any type or a history of malignancy = 5 years prior to visit 1, except for basal cell carcinoma of the skin that has been excised = 12 weeks prior to visit 1.
- •19. History of substance abuse or dependence = 52 weeks prior to visit 1, excluding nicotine and caffeine.
- •20. Subjects with moderately severe or severe depression as indicated by Patient Health Questionnaire-9 total score of = 15 or a score of > 0 on item # 9 at visit 1.
- •21. Subjects with severe anxiety as indicated by Generalized Anxiety Disorder score of = 15 at visit 1.
- •22. Subjects with clinically relevant level of catastrophizing defined as Pain Catastrophizing Scale score of = 30 at visit 1.
- •23. Known allergy or sensitivity to the study medication or its components.
- •24. Females who are pregnant, nursing, or planning a pregnancy during the study period.
- •25. Females of childbearing potential, not using a reliable means of contraception
- •26. Current enrol
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