EUCTR2017-000355-46-PL进行中（未招募）1 期
A Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal®) to Provide Symptomatic Relief of Osteoarthritis of the Knee - not available
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
- 576
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
- •Screening :
- •1. 40-75 years old, Body Mass Index (BMI) = 40 kg/m2.
- •2. Kellgren-Lawrence (K-L) severity grade I, II or III in the index knee as determined by X-ray. Contralateral knee: K-L severity grade 0, I or II.
- •3. at least two signs and at least two symptoms of OA disease (based on the EULAR recommendations) in the index knee for at least 6 months despite conservative treatment (weight reduction, physical therapy, pain medications, etc.). The EULAR signs and symptoms are as follows:
- •o Signs: crepitus, restricted movement and bony enlargement
- •o Symptoms: persistent knee pain, limited morning stiffness and reduced function
- •4. willing to abstain from other IA treatments of the knee for the duration of the study.
- •5. willing to discontinue all analgesics including NSAIDs, except acetaminophen/paracetamol, at least seven days before the treatment injection and through the completion of the study.
- •6. willing to use only acetaminophen/paracetamol for the treatment of joint pain for the duration of the study. At least forty eight hours prior to the Baseline Visit and each follow-up visit, willing to discontinue use of acetaminophen/paracetamol.
- •7. willing to maintain a stable dose of oral glucosamine and/or chondroitin sulfate products throughout the study
- •8. able to understand and comply with the requirements of the study and voluntarily provides consent.
- •1. WOMAC pain-sub-score = 40 mm and = 90 mm in the affected knee and = 30 mm in the contralateral knee on a 100 mm Visual Analog Scale (VAS) scale.
- •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 519
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 57
排除标准
- •1. received an IA injection of Hyaluronic Acid (HA) and/or steroid in either knee within 6 months of signing the informed consent form (ICF). A subject will be excluded if they are planning to receive an HA or steroid injection (other than the study injection) in either knee during the course of this study.
- •2. had an arthroscopy of either knee within 3 months of signing the ICF.
- •3. had an open surgical procedure of either knee or hip or any surgery of the spine within 12 months of signing ICF. Subject plans to have knee, hip or spine surgery within the study period.
- •4. has intra-articular trauma to the index knee. Subject has concurrent multi-system or multi-limb trauma.
- •5. has evidence or medical history of the following diseases in the index knee: septic arthritis; inflammatory joint disease; history of Reiter’s syndrome; gout; chondrocalcinosis associated with recurrent episodes of acute synovitis of the knee consistent with pseudogout; osteochondritis dissecans, Paget disease of the bone; ochronosis; acromegaly; hemochromatosis; primary osteochondromatosis; known history of Wilson disease; heritable disorders or collagen gene mutations.
- •6. has a history of cartilage repair surgery in the index knee within 3 years of signing the ICF.
- •7. has a history of ACL repair, reconstruction or injury in the index knee within 3 years of signing the ICF.
- •8. has X-ray findings of acute fractures, severe bone loss, avascular necrosis, severe bone or joint deformity in the index knee.
- •9. has significant varus or valgus deformity greater than 10 degrees in either knee.
- •10. has a clinically apparent tense effusion of the index knee.
- •11. has knee instability in either knee per the Investigator’s assessment.
- •12. requires consistent use of an assistive device (e.g. wheelchair, walker, etc.) Occasional use of a cane is acceptable.
- •13. has medical condition(s) which could affect study assessments or may adversely affect the safety and/or success of the study treatment. (for list of potential conditions refer to protocol)
- •14. is taking medications at the time the subjects signs the ICF which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study.
- •15. is receiving treatment using electromagnetic stimulation and/or low intensity ultrasound in the index knee at the time of signing the ICF, within 3 months of signing the ICF or plans to receive treatment any time during the study period.
- •16. had an oral, intramuscular, intravenous, rectal suppository or topical (excluded in index knee only) corticosteroid within 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index knee is allowed.
- •17. has a pre-treatment contraindication to IA injections or aspiration of the index knee, including cutaneous infection in the injection site area, active IA infection (as suggested by moderate or marked effusion), knee deformity or condition which, in the opinion of the Investigator could jeopardize the sterility or delivery of the IA injection.
- •18. with a history of hypersensitivity to any of the ingredients in the hyaluronan or previous hypersensitivity to the administration of corticosteroids or an inability to tolerate acetaminophen
研究者
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