None listed
Conditions
Interventions
Group 1 Type of group
Single daily dose of 50 mg of SD-6010 for 24 months
Group name:Group 3 Type of group
single daily doses of placebo for 24 months
Sponsors
PFIZER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • 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 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.
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Joint space narrowing will be analyzed using a mixed effects model for repeated measurements (MMRM) with an effect on the randomized subject and the fixed effects per treatment group, KLG (stratification factor), center / region and baseline JSW. Measure:joint space length and the JSN Timepoints:During the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Analogous Visual Scale (VAS) of Evaluation by the Arthritic Pain Patient. The VAS of Pain is a horizontal line of 100 mm in length with limits in 0 and 100. It is a self-applied instrument. Measure:Arthritic pain Timepoints:Subjects will answer this instrument on Day 1 (baseline), and visits of Months 3, 6, 12, 18 and 24 (or 30), or on the EW visit. ; Outcome name:The General Evaluation by the Patient, of the Arthritic Condition, is a self-applicable evaluation, planned to provide a qualitative measurement of the general impression the subject has of the activity of his or her condition. Measure:Arthritic condition Timepoints:Subjects will answer this instrument on Day 1 (baseline), and visits of Months 3, 6, 12, 18 and 24 (or 30), or on the EW visit. ; Outcome name:Subjects will be asked to evaluate the pain caused by OA on their study knee, after a 50 step walk. This is a single reagent self-application instrument, similar to the VAS of Pain. Measure:Pain After a 50 Step Walk Timepoints:The subjects will answer this instrument on Day 1 (baseline), and the visits of Months 3, 6, 12, 18 and 24 (or 30), or on the visit of EW. ; Outcome name:Subjects will be asked to consider any changes they have experienced since they started with the study medication, taking into account all changes, even if they do not feel that they are completely due, to treatment with the drug. Measure:General Impression of Change by the Patient Timepoints:The subjects will answer this instrument during the visits of Months 24 or 30 | — |
Countries
Belgium, Czech Republic, Germany, Hungary, Italy, Peru, Spain
Outcome results
None listed