EUCTR2004-005261-38-GB进行中（未招募）1 期
A Multicenter, Parallel, Double-Blind, Blinded Evaluator, Randomized Comparison of the Efficacy and Safety of an Alternate Viscosupplement (AVS-beta) to Methylprednisolone Acetate in Patients with Symptomatic Osteoarthritis of the Knee
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
- 372
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
入选标准
- •A patient may be enrolled in this study if he/she meets all of the following criteria:
- •1. Provides signed written informed consent.
- •2. Is able to read and understand the language and content of the study material, understand the requirements for follow-up visits, and is willing to provide information at the scheduled evaluations.
- •3. Is a male or female patient aged 40 years or older
- •4. Is ambulatory (assistive devices are allowed if used 3 months or more prior to Screening) with an active lifestyle and in good general health
- •5. Has documented diagnosis of OA of the target knee where the disease has existed for at least 3 months prior to Screening. Radiographic evidence of OA of the target knee at screening is considered adequate
- •6. Currently meets American College of Rheumatology (ACR) Criteria for OA as noted below:
- •o Knee pain for most days of prior month, and
- •o Osteophytes at joint margins (radiograph)
- •o Knee pain for most days of prior month, and
- •o Synovial fluid typical of OA (laboratory), and
- •o Morning stiffness = 30 minutes in duration, and
- •o Crepitus on active joint motion
- •o Knee pain for most days of prior month, and
- •o Age = 40 years, and
- •o Morning stiffness = 30 minutes in duration, and
- •o Crepitus on active joint motion
- •7. Has continued target knee OA pain despite conservative treatment (e.g., weight reduction, physical therapy, analgesics)
- •8. Is willing to withhold intake of NSAIDs (including cyclooxygenase-2 [COX-2] inhibitors) and analgesics, for a washout period of up to 21 days (depending on medication).
- •9. Is willing to discontinue prohibited treatments and medications throughout the study duration
- •10. Is willing to withhold intake of pain medications for 48 hours prior to all study visits
- •11. If female, must have a negative serum pregnancy test (at Screening) and use a medically acceptable form of contraception for at least 1 month prior to Screening and continue use for the duration of the study. Otherwise, females must be surgically sterile, or postmenopausal (as documented in medical history) for at least 1 year.
- •12. Continues to meet all Screening inclusion/exclusion criteria
- •13. Has completed the pain and OA medication washout period
- •14. Has pain in the target knee as demonstrated by a score of 2 or 3 on the WOMAC LK 3.1 A1
- •15. Has a mean score of 1.5 to 3.5 on the WOMAC LK 3.1 A at Baseline (Day 0)
- •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
- •A patient will be excluded from this study if he/she does not meet the specific inclusion criteria, or if he/she is/has:
- •1. Modified Kellgren-Lawrence Numerical Grading System of grade 0 or grade IV for the target knee confirmed by radiographs performed within 3 months prior to Screening (see definitions below): (0) None: No Features of OA (IV) Severe: Joint space greatly impaired, with sclerosis of subchondral bone
- •2. Clinically apparent tense effusion of the target knee
- •3. Significant valgus/varus deformities, ligamentous laxity, or meniscal instability as assessed by the Investigator
- •4. Acute disease or trauma leading to secondary OA of the target knee within 10 years prior to screening
- •5. Viscosupplementation in any joint including the target knee within 12 months prior to Screening
- •6. Had arthroplasty at the target knee at any time or any other previous surgery in the target knee within the 6 months prior to Screening, or planned surgery throughout the duration of the study
- •7. Receiving physical therapy (at an outpatient/clinic setting) for the target knee that was initiated within 1 month before Screening
- •8. History of septic arthritis in any joint
- •9. Concomitant inflammatory disease or other condition that affects the joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, gout, chondrocalcinosis and active infection, etc.)
- •10. Symptomatic peripheral vascular disease of the study leg (prior or current)
- •11. Clinically significant venous or lymphatic stasis present in the study leg
- •12. Using protocol-prohibited medication/treatments for chronic pain that patient cannot be withdrawn from prior to study treatment at Baseline and throughout the duration of the study
- •13. Any musculoskeletal condition that would impede measurement of efficacy at the target knee
- •14. Symptomatic OA of the contralateral knee or of the ipsilateral hip, or symptomatic patello-femoral OA of the target knee, that is not responsive to acetaminophen / paracetamol (APAP) and requires other therapy
- •15. Systemic, or IA injection of corticosteroids in any joint within 3 months prior to Screening
- •16. Active infection, or history of an infection within the past 12 months, in the area to be injected
- •17. Any significant chronic skin disorder that could interfere with evaluation of the injection site
- •18. Heparin or crystalline warfarin (i.e., Coumadin®) anticoagulant therapy
- •19. Any known contraindication to acetaminophen/paracetamol (APAP
- •20. Any known contraindication to IA corticosteroids
- •21. Started the use of glucosamine, chondroitin sulfate, diacerhein, or avocado/soya extracts within 2 months prior to Screening
- •22. Uncontrolled diabetes mellitus, diabetic neuropathy, or infectious complications; end-stage hepatic or renal disease; or patients on immunosuppressive therapy
- •23. Current malignancy or treatment for malignancy within the past 5 years, except non-melanoma skin cancer
- •24. Active asthma that may require periodic treatment with systemic steroids during the study period (note: inhaled steroids for this condition are allowed)
研究者
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