{
  "FullStudy":{
    "Rank":217834,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516229",
          "OrgStudyIdInfo":{
            "OrgStudyId":"GH-1941"
          },
          "Organization":{
            "OrgFullName":"Novo Nordisk A/S",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Special Survey for Long Term Application",
          "OfficialTitle":"Specific Survey of Norditropin® in Achondroplasia: Survey for Long-term Application"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2017",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"May 1, 1997",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 31, 2007",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 31, 2007",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 23, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 27, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Novo Nordisk A/S",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This study is conducted in Japan. The aim of this study is to assess the incidence rate of adverse drug reactions (ADRs) when using somatropin (Norditropin®) for treatment of for achondroplasia without epiphyseal line closure under normal clinical practice conditions."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Genetic Disorder",
              "Achondroplasia"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "PatientRegistry":"No",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"395",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Somatropin",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: somatropin"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"somatropin",
                "InterventionDescription":"Prescription of somatropin at the discretion of the physician",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Somatropin"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Incidence of adverse drug reactions (ADRs)"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Treatment evaluation using the Foundation for Growth Science's Criteria for Treatment Continuation: Definitely effective, effective, ineffective or definitely ineffective"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAchondroplasia without epiphyseal line closure",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"1 Year",
          "MaximumAge":"15 Years",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          },
          "StudyPopulation":"Patients being treated with somatropin for achondroplasia without epiphyseal line closure",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Global Clinical Registry (GCR, 1452)",
                "OverallOfficialAffiliation":"Novo Nordisk A/S",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Novo Nordisk Investigational Site",
                "LocationCity":"Tokyo",
                "LocationZip":"1000005",
                "LocationCountry":"Japan"
              },{
                "LocationFacility":"Novo Nordisk Investigational Site",
                "LocationCity":"Tokyo",
                "LocationZip":"103",
                "LocationCountry":"Japan"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Clinical Trials at Novo Nordisk",
                "SeeAlsoLinkURL":"http://novonordisk-trials.com"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000000130",
                "ConditionMeshTerm":"Achondroplasia"
              },{
                "ConditionMeshId":"D000030342",
                "ConditionMeshTerm":"Genetic Diseases, Inborn"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000004392",
                "ConditionAncestorTerm":"Dwarfism"
              },{
                "ConditionAncestorId":"D000001848",
                "ConditionAncestorTerm":"Bone Diseases, Developmental"
              },{
                "ConditionAncestorId":"D000001847",
                "ConditionAncestorTerm":"Bone Diseases"
              },{
                "ConditionAncestorId":"D000009140",
                "ConditionAncestorTerm":"Musculoskeletal Diseases"
              },{
                "ConditionAncestorId":"D000010009",
                "ConditionAncestorTerm":"Osteochondrodysplasias"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M2075",
                "ConditionBrowseLeafName":"Achondroplasia",
                "ConditionBrowseLeafAsFound":"Achondroplasia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M22270",
                "ConditionBrowseLeafName":"Genetic Diseases, Inborn",
                "ConditionBrowseLeafAsFound":"Genetic Disorders",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M6149",
                "ConditionBrowseLeafName":"Dwarfism",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3708",
                "ConditionBrowseLeafName":"Bone Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3709",
                "ConditionBrowseLeafName":"Bone Diseases, Developmental",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10680",
                "ConditionBrowseLeafName":"Musculoskeletal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10626",
                "ConditionBrowseLeafName":"Mucopolysaccharidosis IV",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11515",
                "ConditionBrowseLeafName":"Osteochondrodysplasias",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T102",
                "ConditionBrowseLeafName":"Achondroplasia",
                "ConditionBrowseLeafAsFound":"Achondroplasia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T3931",
                "ConditionBrowseLeafName":"Mucopolysaccharidosis Type IV",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC05",
                "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC16",
                "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC17",
                "ConditionBrowseBranchName":"Skin and Connective Tissue Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}