[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100168238":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":34,"centralContacts":11,"locations":38,"responsibleParty":51,"collaborators":11,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":11,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":11,"enrollmentInfo":62,"targetDuration":11,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":11,"overallStatus":71,"whyStopped":11,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Sanofi","INDUSTRY",[8,14,17,20],{"label":9,"type":10,"description":11,"interventionNames":12},"SAR113945 - Dose 1","EXPERIMENTAL",null,[13],"Drug: SAR113945",{"label":15,"type":10,"description":11,"interventionNames":16},"SAR113945 - Dose 2",[13],{"label":18,"type":10,"description":11,"interventionNames":19},"SAR113945 - Dose 3",[13],{"label":21,"type":22,"description":11,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR",[24],"Drug: placebo",[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"DRUG","SAR113945","Pharmaceutical form:Injection\n\nRoute of administration: Intra-articular",[9,15,18],{"type":27,"name":32,"description":29,"armGroupLabels":33,"otherNames":11},"placebo",[21],[35],{"name":36,"affiliation":5,"role":37},"Clinical Sciences & Operations","STUDY_DIRECTOR",[39],{"facility":40,"status":11,"city":41,"state":11,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":11},"Investigational Site Number 276001","Berlin","14050","Germany","DE",{"type":46,"coordinates":47},"Point",[48,49],13.41053,52.52437,{"lat":49,"lon":48},{"type":52,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100168238","phase-1-safety-of-single-doses-of-sar113945-and-efficacy-and-safety-of-a-new-formulation-given-into-the-knee-in-osteoarthritis-patients--part-i-100168238",false,"NCT01463488","Safety of Single Doses of SAR113945 and Efficacy and Safety of a New Formulation Given Into the Knee in Osteoarthritis Patients \u002F Part I","A Two Part Protocol to Assess, Using Double Blind Placebo Control, the Safety, Tolerability, and Pharmacokinetics of Ascending Single Doses of a New Intra-articular Administration Formulation of SAR113945 (IKK Inhibitor) Followed by Assessment of Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose in Patients With Knee Osteoarthritis","Inclusion criteria:\n\n\\- Diagnosis of primary knee osteoarthritis, based upon the following:\n\n* X-ray or Magnetic Resonance Imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation\n* Patients will be Kellgren and Lawrence classification II\u002FIII, and total Western Ontario McMaster (WOMAC) score 24 -72.\n* Patients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis.\n\nExclusion criteria:\n\n* Patients younger than 40 years\n* Women of child bearing potential.\n* Women either sterilized for more than 3 months, or post-menopausal for more than 12 months. Menopause is defined as over age of 60 years or being amenorrheic for at least 2 years with plasma FSH level \\>30 IU\u002FL.\n* Secondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos Syndrome, Gaucher's disease, Stickler's syndrome, joint infection, haemophilia, haemochromatosis, calcium pyrophosphate deposition disease, or neuropathic arthropathy.\n* Presence of local skin abnormality at the affected knee joint.\n* Intra-articular injection within 3 months.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.","ALL","40 Years",{"count":63,"type":64},24,"ACTUAL","INTERVENTIONAL",[67],"PHASE1","Study objectives:\n\n* Part 1 TDU11685 To assess in patients with knee Osteoarthritis (OA), the safety, tolerability and pharmacokinetics (PK) of single intra-articular doses of SAR113945.\n* Part 2 ACT12505 To assess in patients with knee OA, the efficacy, safety and tolerability of a single intra-articular dose of SAR113945.",[70],"Knee Osteoarthritis","COMPLETED","2012-08-22",{"date":74,"type":75},"2012-08-23","ESTIMATED",{"date":77,"type":11},"2011-11",{"date":79,"type":64},"2012-08",{"name":5,"class":6},1]