{
  "FullStudy":{
    "Rank":218191,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01511549",
          "OrgStudyIdInfo":{
            "OrgStudyId":"TDU11333"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"U1111-1121-4499",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"UTN"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Sanofi",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Safety, Tolerability and Pharmacokinetics of SAR113945 in Japanese Patients With Knee Osteoarthritis",
          "OfficialTitle":"A Randomized, Double-blind, Placebo-controlled Ascending Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of SAR113945 (IKK Inhibitor) Following Intra-articular Administration in Japanese Patients With Knee Osteoarthritis"
        },
        "StatusModule":{
          "StatusVerifiedDate":"September 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 6, 2012",
          "StudyFirstSubmitQCDate":"January 12, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"September 28, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 1, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Sanofi",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Primary Objective:\n\nTo assess the safety and tolerability of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses\n\nSecondary Objective:\n\nTo assess the pharmacokinetics of SAR113945 in Japanese patients with knee osteoarthritis after ascending single intra-articular doses",
          "DetailedDescription":"Following the single dose of study medication, the study period for each patient will be 168 days."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Knee Osteoarthritis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"24",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Dose 1",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"SAR113945 low dose",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: SAR113945"
                  ]
                }
              },{
                "ArmGroupLabel":"Dose 2",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"SAR113945 medium dose",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: SAR113945"
                  ]
                }
              },{
                "ArmGroupLabel":"Dose 3",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"SAR113945 high dose",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: SAR113945"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Placebo",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"placebo",
                "InterventionDescription":"Pharmaceutical form:injection\n\nRoute of administration: intra-articular",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"SAR113945",
                "InterventionDescription":"Pharmaceutical form:injection\n\nRoute of administration: intra-articular",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Dose 1",
                    "Dose 2",
                    "Dose 3"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of patients with safety assessments (adverse events, vital signs, 12 lead ECGs and laboratory tests)",
                "PrimaryOutcomeTimeFrame":"up to 24 weeks"
              },{
                "PrimaryOutcomeMeasure":"Examination of skin/soft tissue of injected knee, and knee joint",
                "PrimaryOutcomeDescription":"Examination of skin/soft tissue of injected knee: Any reaction is classified as erythema, edema, pain, hematoma and graded none, mild, moderate or severe.\n\nExamination of knee joint of injected knee: Any reaction is classified as effusion/worsening of effusion, warmth and pain.",
                "PrimaryOutcomeTimeFrame":"up to 24 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Pharmacokinetic parameter (AUC)",
                "SecondaryOutcomeTimeFrame":"21 time points up to 24 weeks"
              },{
                "SecondaryOutcomeMeasure":"Pharmacokinetic parameter (Cmax)",
                "SecondaryOutcomeTimeFrame":"21 time points up to 24 weeks"
              },{
                "SecondaryOutcomeMeasure":"Pharmacokinetic parameter (tmax)",
                "SecondaryOutcomeTimeFrame":"21 time points up to 24 weeks"
              },{
                "SecondaryOutcomeMeasure":"Pharmacokinetic parameter (t1/2)",
                "SecondaryOutcomeTimeFrame":"21 time points up to 24 weeks"
              },{
                "SecondaryOutcomeMeasure":"Pharmacodynamic parameter (WOMAC index)",
                "SecondaryOutcomeTimeFrame":"up to 24 weeks"
              },{
                "SecondaryOutcomeMeasure":"Pharmacodynamic parameter (biomarkers relating to osteoarthritis)",
                "SecondaryOutcomeTimeFrame":"up to 24 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion criteria:\n\nJapanese male or female patients, aged 40 years or older, with knee osteoarthritis\n\nDiagnosis of primary knee osteoarthritis, based upon the following:\n\nX-ray or magnetic response imaging (MRI) evidence within the last 6 months for joint space narrowing and osteophyte formation\nPatients will be Kellegen and Lawrence classification II or III, and total Western Ontario McMaster (WOMAC) score below or equal to 72\nPatients fulfilling the American College of Rheumatology Clinical and Radiographic criteria for Osteoarthritis\n\nExclusion criteria:\n\nWomen of child bearing potential\nSecondary osteoarthritis: e.g., autoimmune disease, joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, Ehlers-Danlos syndrome, Gaucher's disease, Stickler's syndrome, joint infection, hemophilia, hemochromatosis, calcium pyrophosphate disposition disease, or neuropathic arthropathy\nPresence of local skin abnormality at the affected knee joint\nAny patient who received intra-articular injection within 3 months prior to administration\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"40 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Clinical Sciences & Operations",
                "OverallOfficialAffiliation":"Sanofi",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Investigational Site Number 392001",
                "LocationCity":"Osaka-Shi",
                "LocationZip":"532-0003",
                "LocationCountry":"Japan"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000010003",
                "ConditionMeshTerm":"Osteoarthritis"
              },{
                "ConditionMeshId":"D000020370",
                "ConditionMeshTerm":"Osteoarthritis, Knee"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000001168",
                "ConditionAncestorTerm":"Arthritis"
              },{
                "ConditionAncestorId":"D000007592",
                "ConditionAncestorTerm":"Joint Diseases"
              },{
                "ConditionAncestorId":"D000009140",
                "ConditionAncestorTerm":"Musculoskeletal Diseases"
              },{
                "ConditionAncestorId":"D000012216",
                "ConditionAncestorTerm":"Rheumatic Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M11509",
                "ConditionBrowseLeafName":"Osteoarthritis",
                "ConditionBrowseLeafAsFound":"Osteoarthritis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M20752",
                "ConditionBrowseLeafName":"Osteoarthritis, Knee",
                "ConditionBrowseLeafAsFound":"Knee Osteoarthritis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3057",
                "ConditionBrowseLeafName":"Arthritis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9204",
                "ConditionBrowseLeafName":"Joint Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10680",
                "ConditionBrowseLeafName":"Musculoskeletal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13628",
                "ConditionBrowseLeafName":"Rheumatic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4906",
                "ConditionBrowseLeafName":"Collagen Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC05",
                "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC17",
                "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases"
              }
            ]
          }
        }
      }
    }
  }
}