{
  "FullStudy":{
    "Rank":218268,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510535",
          "OrgStudyIdInfo":{
            "OrgStudyId":"LG-HACL010"
          },
          "Organization":{
            "OrgFullName":"LG Life Sciences",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis",
          "OfficialTitle":"An Double-blind, Active-controlled, Parallel-group, Randomized, Multi-center Study to Compare Efficacy and Safety of LBSA0103 Once Versus Hyruan Plus Injection Once Weekly for 3weeks in the Treatment of Patients With Osteoarthritis of the Knee"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"December 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"October 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 6, 2012",
          "StudyFirstSubmitQCDate":"January 11, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 16, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 17, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"LG Life Sciences",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to compare efficacy and safety of intra-articular LBSA0103 once versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3 weeks in the treatment of patients with osteoarthritis of the knee."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Osteoarthritis of the Knee"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Osteoartritis",
              "Knee",
              "LBSA0103",
              "Hyruan Plus Inj."
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"287",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Placebo and then LBSA0103",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"The experimental group receive once weekly for 2 weeks intraarticular injections of Placebo(saline). And then, they receive once intraarticular injections of LBSA0103 into the target knee.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo",
                    "Drug: LBSA0103"
                  ]
                }
              },{
                "ArmGroupLabel":"Hyruan Plus",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"The control group received once weekly for 3 weeks intraarticular injections of Hyruan Plus Inj. into the target knee.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Hyruan Plus"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Placebo",
                "InterventionDescription":"First 2 weeks Placebo(2ml) once weekly in experimental group",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo and then LBSA0103"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Hyruan Plus",
                "InterventionDescription":"Hyruan Plus Inj. (2ml)once weekly for 3 weeks in control group",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Hyruan Plus"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"LBSA0103",
                "InterventionDescription":"at third week LBSA0103(60mg) once in experimental group",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo and then LBSA0103"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Weight-bearing pain",
                "PrimaryOutcomeDescription":"using 100mm-VAS",
                "PrimaryOutcomeTimeFrame":"12 weeks after the last injection"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Weight-bearing pain",
                "SecondaryOutcomeDescription":"using 100mm-VAS",
                "SecondaryOutcomeTimeFrame":"1,6 weeks after the last injection"
              },{
                "SecondaryOutcomeMeasure":"WOMAC-likert assessment",
                "SecondaryOutcomeDescription":"Pain, Function, Stiffness, Total score",
                "SecondaryOutcomeTimeFrame":"1,6,12 weeks after the last injection"
              },{
                "SecondaryOutcomeMeasure":"Patient Global Assessment",
                "SecondaryOutcomeDescription":"using 100mm-VAS",
                "SecondaryOutcomeTimeFrame":"1,6,12 weeks after the last injection"
              },{
                "SecondaryOutcomeMeasure":"Investigator Global Assessment",
                "SecondaryOutcomeDescription":"using 100mm-VAS",
                "SecondaryOutcomeTimeFrame":"1,6,12 weeks after the last injection"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nOver 40 years of age\nKellgren & Lawrence grade I-III\nIf there is more than one knee having a weight bearing pain of at least 40mm evaluated by 100mm VAS\nBe willing to discontinue all nonsteroidal anti-inflammatory drugs(NSAIDs), analgesics, condroichin sulfate/glucosamine or physical therapy for the duration of the study\n\nExclusion Criteria:\n\nBody mass index > 32\nHave rheumarthritis\nPatients who have a weight-bearing pain of less than 40mm on both knees when measured by 100mm-VAS\nHave Sudek's atrophy, Paget's disease, Spinal disc herniation\nKellgren & Lawrence Grade IV",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"40 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Seoul National University Hospital",
                "LocationCity":"Jongno-gu",
                "LocationState":"Seoul",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"28549436",
                "ReferenceType":"derived",
                "ReferenceCitation":"Ha CW, Park YB, Choi CH, Kyung HS, Lee JH, Yoo JD, Yoo JH, Choi CH, Kim CW, Kim HC, Oh KJ, Bin SI, Lee MC. Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study. BMC Musculoskelet Disord. 2017 May 26;18(1):223. doi: 10.1186/s12891-017-1591-4."
              }
            ]
          }
        }
      },
      "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":"Osteoarthritis of the Knee",
                "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"
              }
            ]
          }
        }
      }
    }
  }
}