PER-020-08已完成未知
A LONG-TERM, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED, RADIOGRAPHIC STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF ORALLY ADMINISTERED SD-6010 IN SUBJECTS WITH SYMPTOMATIC OSTEOARTHRITIS OF THE KNEE
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- PFIZER S.A.,
- 入组人数
- 111
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Informed consent has been granted in writing and you wish to comply with scheduled visits, treatment plan, radiographs, laboratory tests and all other procedures;
- •Is a woman with an age> 40 years with a BMI> 30 and <40 kg / m2;
- •In the past, you have been diagnosed with OA of the knee and have presented symptoms in the knee during the previous year, defined as: Pain, stitches or stiffness during most days of a month; and / or uses a medication (other than powerful opioids) for the treatment of knee pain on most days of a month;
- •Have a current level of pain (apart from an acute exacerbation) in at least 1 knee, characterized by a classification in the WOMAC Pain subscale of between 6 and 12, inclusive (where the range of sub-ratings is 0-20) ; Note: Pain should be characterized as the subject´s normal pain day after day while on standard care medication and pain is not related to an acute exacerbation.
- •Has been on the same standard OA knee pain medication (s) for at least 3 months, and with a stable dosing regimen for at least 4 weeks prior to first dose of the study medication (stable is defined as: Dosage and frequency of administration that remains unchanged);
- •Does not present pregnancy potential, if it meets one of the following two categories: Is> 45 years of age and is amenorrheic for at least 2 years, or Has a documented medical test of hysterectomy and or bilateral oophorectomy.
- •If you have potential for pregnancy, you must have accepted that when you are sexually active, you must use effective contraceptive methods outlined in the protocol, and adhere to the timeframes described in Section 4.5.1.1.
排除标准
- •A diagnosis of any other rheumatic disease (eg, spondyloarthropathies, rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, etc.);
- •Current, severe, non-controlled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or any other condition that made the subject unsuitable for the study, within 6 months prior to the visit of Selection, patients controlled with renal dialysis will be excluded.
- •Uncontrolled diabetes, uncontrolled hyperglycemia, active infection of a foot wound, or a history of diabetic ulcer. Any treatment plan where serum glucose is maintained at normal levels is considered controlled. If during the course of the study, the subject´s condition becomes less controlled, the treating physician must control the subject without withdrawing it from the study; however, once it is determined that the subject´s condition is uncontrollable in the long term, the subject should be discontinued from the study. The consultation with the matante doctor is adequate.
- •Clinically significant infections (acute infection or those requiring hospitalization or parenteral antimicrobial therapy) during the 6 months prior to the visit of Selection 1;
- •An active malignant disease of any type, or a history of malignant disease (except for subjects who underwent surgical removal and no evidence of recurrence in the last 5 years, except for subjects with a history of carcinoma no melanoma treated)
- •Any known disease or condition that could affect the knees, including, but not limited to, lens disease (eg, gout, pseudogout), endocrinopathies, (eg, acromegaly), metabolic disorders (eg, ochronosis, hemochromatosis, Wilson, Gaucher´s disease) septic arthritis, neuropathic disorders, mechanical disorders (eg hypermobility), avascular necrosis, intra-articular fracture, microfractures, debridement, chondrocyte thomasplasty, osteotomy, arthroplasty, mosaicoplasty, ACL rupture, partial or total meniscotomy, osteophyte resection , or any other injury related to knee tissues, Piaget´s disease, tumors, (eg, primary osteochondromatosis), or genetic mutations of collagen; Note: If any of the above findings affect both knees - SUSPEND the selection (Selection Failure). However, if a finding only affects 1 rodil, the other can be qualified as the study knee, but only after a radiological evaluation has been made. Please document any findings in the corresponding CRF.
- •Significant knee trauma (including arthroscopy or significant injury to the ligaments or meniscus of the knee in the year preceding the visit of Selection 1) Note: If a finding affects both knees SUSPEND the selection (Selection Failure). However, if a finding only affects 1 knee, the other can be qualified as the study knee, but only after a radiological evaluation has been made, please document any findings in the corresponding CRF.
- •Alcoholism or drug abuse in the year preceding the visit of the National Team
- •A verified history of systolic blood pressure> 150 mm Hg (if not treated for hypertension) or more than 160 mm Hg (if treated for hypertension) and / or diastolic blood pressure greater than 90 mm Hg;
- •A finding in the ECG that the researcher considered to be clinically significant;
- •Any morbidity condition (eg, coronary heart disease, hypertension, dyspnea, diabetes, obesity, COPD, emphysema, depression, severe OA) that could impair related work or the relative time of p
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