{
  "FullStudy":{
    "Rank":217695,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518036",
          "OrgStudyIdInfo":{
            "OrgStudyId":"GHTUR/BPD/1"
          },
          "Organization":{
            "OrgFullName":"Novo Nordisk A/S",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Use of Somatropin in Turner Syndrome",
          "OfficialTitle":"The Use of Norditropin® in Turner's Syndrome"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2017",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 14, 1987",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"April 11, 2004",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"April 11, 2004",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 20, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 27, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 28, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Novo Nordisk A/S",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"This trial is conducted in Europe. The aim of this trial is to study the dose-response relationship and effect of somatropin (Norditropin®) on final height in girls with Turner Syndrome."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Genetic Disorder",
              "Turner Syndrome"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"57",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Low dose",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: somatropin"
                  ]
                }
              },{
                "ArmGroupLabel":"High dose",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: somatropin"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"somatropin",
                "InterventionDescription":"2.9 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Low dose"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"somatropin",
                "InterventionDescription":"4.3 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "High dose"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Final height in cm"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Ratio between change in bone age and change in chronological age"
              },{
                "SecondaryOutcomeMeasure":"Age at onset of puberty"
              },{
                "SecondaryOutcomeMeasure":"Adverse events"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nTurner Syndrome\nNot previously treated with growth hormone or androgen\nWell-documented height over the previous 12 months\nInformed consent of parents (and child if appropriate)\n\nExclusion Criteria:\n\nGrowth hormone (GH) deficiency based on a GH stimulation test",
          "HealthyVolunteers":"No",
          "Gender":"Female",
          "MinimumAge":"2 Years",
          "MaximumAge":"11 Years",
          "StdAgeList":{
            "StdAge":[
              "Child"
            ]
          }
        },
        "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":"Crawley",
                "LocationZip":"RH11 9RT",
                "LocationCountry":"United Kingdom"
              }
            ]
          }
        },
        "ReferencesModule":{
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Clinical Trials at Novo Nordisk",
                "SeeAlsoLinkURL":"http://novonordisk-trials.com"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000014424",
                "ConditionMeshTerm":"Turner Syndrome"
              },{
                "ConditionMeshId":"D000006059",
                "ConditionMeshTerm":"Gonadal Dysgenesis"
              },{
                "ConditionMeshId":"D000030342",
                "ConditionMeshTerm":"Genetic Diseases, Inborn"
              },{
                "ConditionMeshId":"D000013577",
                "ConditionMeshTerm":"Syndrome"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000004194",
                "ConditionAncestorTerm":"Disease"
              },{
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000012734",
                "ConditionAncestorTerm":"Disorders of Sex Development"
              },{
                "ConditionAncestorId":"D000014564",
                "ConditionAncestorTerm":"Urogenital Abnormalities"
              },{
                "ConditionAncestorId":"D000058533",
                "ConditionAncestorTerm":"Sex Chromosome Disorders of Sex Development"
              },{
                "ConditionAncestorId":"D000006330",
                "ConditionAncestorTerm":"Heart Defects, Congenital"
              },{
                "ConditionAncestorId":"D000018376",
                "ConditionAncestorTerm":"Cardiovascular Abnormalities"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              },{
                "ConditionAncestorId":"D000006331",
                "ConditionAncestorTerm":"Heart Diseases"
              },{
                "ConditionAncestorId":"D000000013",
                "ConditionAncestorTerm":"Congenital Abnormalities"
              },{
                "ConditionAncestorId":"D000025064",
                "ConditionAncestorTerm":"Sex Chromosome Disorders"
              },{
                "ConditionAncestorId":"D000025063",
                "ConditionAncestorTerm":"Chromosome Disorders"
              },{
                "ConditionAncestorId":"D000006058",
                "ConditionAncestorTerm":"Gonadal Disorders"
              },{
                "ConditionAncestorId":"D000004700",
                "ConditionAncestorTerm":"Endocrine System Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M14938",
                "ConditionBrowseLeafName":"Syndrome",
                "ConditionBrowseLeafAsFound":"Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M15757",
                "ConditionBrowseLeafName":"Turner Syndrome",
                "ConditionBrowseLeafAsFound":"Turner Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M7747",
                "ConditionBrowseLeafName":"Gonadal Dysgenesis",
                "ConditionBrowseLeafAsFound":"Turner Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M12",
                "ConditionBrowseLeafName":"Congenital Abnormalities",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M22270",
                "ConditionBrowseLeafName":"Genetic Diseases, Inborn",
                "ConditionBrowseLeafAsFound":"Genetic Disorders",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14128",
                "ConditionBrowseLeafName":"Disorders of Sex Development",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15897",
                "ConditionBrowseLeafName":"Urogenital Abnormalities",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21607",
                "ConditionBrowseLeafName":"Chromosome Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4692",
                "ConditionBrowseLeafName":"Chromosome Aberrations",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21608",
                "ConditionBrowseLeafName":"Sex Chromosome Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8001",
                "ConditionBrowseLeafName":"Heart Defects, Congenital",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M19087",
                "ConditionBrowseLeafName":"Cardiovascular Abnormalities",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8002",
                "ConditionBrowseLeafName":"Heart Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7746",
                "ConditionBrowseLeafName":"Gonadal Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6445",
                "ConditionBrowseLeafName":"Endocrine System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T5789",
                "ConditionBrowseLeafName":"Turner Syndrome",
                "ConditionBrowseLeafAsFound":"Turner Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"T2601",
                "ConditionBrowseLeafName":"Gonadal Dysgenesis",
                "ConditionBrowseLeafAsFound":"Turner Syndrome",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC16",
                "ConditionBrowseBranchName":"Diseases and Abnormalities at or Before Birth"
              },{
                "ConditionBrowseBranchAbbrev":"BC19",
                "ConditionBrowseBranchName":"Gland and Hormone Related Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}