EUCTR2007-001457-26-CZ进行中（未招募）不适用
A LONG-TERM, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP,PLACEBO-CONTROLLED, RADIOGRAPHIC STUDY TO INVESTIGATE THESAFETY AND EFFICACY OF ORALLY ADMINISTERED SD-6010 IN SUBJECTSWITH SYMPTOMATIC OSTEOARTHRITIS OF THE KNEE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,400
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
- •Investigator Level Assessments for Inclusion
- •1. Has provided written informed consent and is willing to comply with scheduled visits,treatment plan, radiographs, laboratory tests, and other trial procedures;
- •2. Age =40 years with a BMI =25 and =40 kg/m2;
- •3. In the past, has been diagnosed with knee OA and has had knee symptoms in the past year defined as:
- •Pain, aching or stiffness on most days of a month; and/or
- •Used a medication (other than potent opioids) for treatment of knee pain on
- •most days of a month;
- •4. If currently being treated for OA knee symptoms, has been on the same standard of care
- •medication(s) and on a stable dosing regimen for at least 4 weeks preceding the first
- •dose of study medication (stable defined as: Doses and frequency of administration
- •remain unchanged);
- •5. If female, is of non-childbearing potential, and 1 of the 2 categories below is satisfied:
- •Is =45 years of age and amenorrheic for at least 2 years, or
- •Has proof of a physician documented hysterectomy and/or bilateral oophorectomy;
- •Note: Females not meeting the non-childbearing rules above or having undergone
- •tubal ligation will be considered of childbearing potential for this study (refer to #6
- •6. If a male, or a female of childbearing potential, has agreed that when sexually active, to use the protocol designated effective methods of contraception and abide by the time frames .
- •Central Imaging Core Laboratory Criteria for Inclusion
- •Subjects meeting the following Screen 1 inclusion criteria by radiography as assessed
- •through the modified Lyon-schuss X-ray will be semi-qualified for Screen 2. Criteria 1-4
- •below will be assessed by the independent Central Reader from data from the Central Imaging Core Laboratory for determining which subjects will be invited back for Screen 2.
- •A yes” answer to each criterion is needed to continue screening.
- •1. KLG 2 or 3 with a medial tibiofemoral joint space width (JSW) =2 mm and more
- •narrowed than the lateral JSW in the study knee;
- •2. KLG <4 in the contralateral knee; unless the contralateral knee has KLG 4 changes and, in the opinion of the Investigator, the subject is unlikely to undergo arthroplasty within the next 2 years, the subject will be considered for eligibility. Conversely, if a subject is at risk of becoming incapacitated in the near future due to the KLG 4 changes such that activities of daily living are severely curtailed, the subject should not be considered for the trial.
- •3. An anatomic axis angle (AAA) between 184° and 174°inclusive. If the study knee has KLG 3 changes and a medial JSW smaller than the lateral JSW with an AAA >184
- •degrees, and if the other radiographic eligibility criteria are met, the subject will be
- •considered for eligibility;
- •4. No radiological findings such as, but not limited to avascular necrosis, fracture, infection, gout, Paget’s disease, osteopetrosis, osteochondritis, or other pathologies in the study knee.
- •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.Subjects with a history of:
- •a.A diagnosis of any other rheumatic disease (eg, spondyloarthropathies, rheumatoid arthritis, systemic lupus erythematosus );
- •b.Severe, uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological disease, or any other condition which would make the subject unsuitable for the study within 6 months preceding the Screen 1 visit;
- •c.Uncontrolled diabetes, uncontrolled hyperglycemia, active foot wound infection, or a history of diabetic ulceration;
- •d.Clinically significant infections (acute infection or those requiring hospitalization or requiring parenteral antimicrobial therapy) within 6 months preceding the Screen 1 visit;
- •e.An active malignancy of any type or history of a malignancy (with the exception of subjects with malignancy surgically removed with no evidence of recurrence within the past 5 years, and with the exception of subjects with a history of treated nonmelanoma carcinoma);
- •f.Any diseases or conditions involving the knees including, but not limited:
- •-Crystalline disease (eg, gout, pseudogout; however, mild to moderate asymptomatic chondrocalcinosis is not an exclusion).
- •-Endocrinopathies (eg, acromegaly)
- •-Metabolic diseases (eg, ochronosis, hemochromatosis, Wilson’s disease, Gaucher’s disease)
- •-Septic arthritis
- •-Neuropathic disorders
- •-Mechanical disorders (eg, hypermobility)
- •-Avascular necrosis
- •-Intra articular fracture
- •-Microfractures, cartilage debridement, chondrocyte transplantation, mosaicplasty
- •-Osteotomy, arthroplasty, osteophyte resection,
- •-Paget’s disease, tumors, (eg, primary osteochondromatosis) or collagen gene mutations
- •-Any injury/trauma of the knee resulting in anterior cruciate ligament (ACL)/posterior cruciate ligament (PCL) rupture or reconstruction and/or partial or total meniscectomy for traumatic meniscal tears; however, a partial or total meniscectomy for degenerative meniscal tears related to OA is not exclusionary.
- •g.Significant trauma to the knees including significant injury to ligaments or menisci of the knee within 1 year preceding the Screen 1 visit;
- •h.Alcoholism or drug abuse within 1 year preceding the Screen 1 visit;
- •2.Subjects presenting with:
- •a.A verified systolic blood pressure >150 mm Hg (if untreated for hypertension) or greater than 160 mm Hg (if treated for hypertension) and/or a diastolic blood pressure greater than 90 mm Hg;
- •b.Any morbidities (eg, coronary heart disease, hypertension, dyspnea, diabetes, obesity, COPD, emphysema, depression, severe OA) that would curtail work related or leisure time physical activities (eg, walking, cooking, gardening, standing) such that these morbidities would contribute to increases in sedentary behaviors (eg, becoming chair or bed ridden, aka, couch potato lifestyle”);
- •c.Chronic potent opioid use for OA of the knees (propoxyphene, tramadol, codeine use is acceptable);
- •d.Any condition possibly affecting oral drug absorption (eg, gastrectomy or clinically significant diabetic gastroenteropathy);
- •e.Exacerbation of OA pain (eg, a flare) in either knee requiring a change in stable treatment within 4 weeks of the Screen 1 visit;
- •f.Symptomatic OA of either hip by history or elicited on physical examination that may confound the interpretation of knee pain; Use of any investigational drug within 1 month preceding the Screen 1 visit;
- •3.Pregnant or breastfeeding females;
- •4.Anticipating a move out of the area of the clinic in the next 2 years;
研究者
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