{
  "FullStudy":{
    "Rank":218243,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510860",
          "OrgStudyIdInfo":{
            "OrgStudyId":"URT-15/PBC"
          },
          "Organization":{
            "OrgFullName":"Dr. Falk Pharma GmbH",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Ursofalk Tablets (500 mg) Versus Ursofalk Capsules (250 mg) in the Treatment of Primary Biliary Cirrhosis",
          "OfficialTitle":"Double-blind, Double-dummy, Randomised, Crossover, Multicentre Phase IV Clinical Study Comparing the Effect of Ursofalk 500 mg Tablets od Versus Ursofalk 250 mg Capsules od on Liver Enzymes in the Treatment of Primary Biliary Cirrhosis"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2008"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2010",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2010",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 12, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"May 3, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"May 7, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Dr. Falk Pharma GmbH",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to compare the efficacy of Ursofalk 500 mg tablets versus Ursofalk 500 mg capsules in the treatment of Primary Biliary Cirrhosis (PBC)."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Primary Biliary Cirrhosis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"65",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Ursodeoxycholic acid (UDCA)250 mg",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"UDCA 250 mg capsule",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: UDCA (Ursodeoxycholic acid)"
                  ]
                }
              },{
                "ArmGroupLabel":"Ursodeoxycholic acid (UDCA)500 mg",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"UDCA 500 mg tablet",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: UDCA (Ursodeoxycholic acid)"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"UDCA (Ursodeoxycholic acid)",
                "InterventionDescription":"250 mg",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Ursodeoxycholic acid (UDCA)250 mg"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"UDCA (Ursodeoxycholic acid)",
                "InterventionDescription":"500 mg",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Ursodeoxycholic acid (UDCA)500 mg"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change of liver enzymes between baseline and the end of the treatment-period with Ursofalk 250 mg capsules and the end of treatment-period with Ursofalk 500 mg tablets.",
                "PrimaryOutcomeTimeFrame":"Between baseline and week 24"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Quality of Life",
                "SecondaryOutcomeTimeFrame":"Between baseline and week 24"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nNegative pregnancy\nSigned informed consent\nHistologically proven non-cirrhotic liver disease\n\nExclusion Criteria:\n\nhistologically proven cirrhosis\nPBC stage II+IV\nPositive HIV serology",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Christian Rust, MD",
                "OverallOfficialAffiliation":"Klinikum Grosshadern Munich",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Klinikum Grosshadern",
                "LocationCity":"Munich",
                "LocationZip":"81377",
                "LocationCountry":"Germany"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"27121784",
                "ReferenceType":"result",
                "ReferenceCitation":"Hopf C, Grieshaber R, Hartmann H, Hinrichsen H, Eisold M, Cordes HJ, Greinwald R, Rust C. Therapeutic Equivalence of Ursodeoxycholic Acid Tablets and Ursodeoxycholic Acid Capsules for the Treatment of Primary Biliary Cirrhosis. Clin Pharmacol Drug Dev. 2013 Jul;2(3):231-6. doi: 10.1002/cpdd.24. Epub 2013 Apr 15."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000014580",
                "InterventionMeshTerm":"Ursodeoxycholic Acid"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000002756",
                "InterventionAncestorTerm":"Cholagogues and Choleretics"
              },{
                "InterventionAncestorId":"D000005765",
                "InterventionAncestorTerm":"Gastrointestinal Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M15912",
                "InterventionBrowseLeafName":"Ursodeoxycholic Acid",
                "InterventionBrowseLeafAsFound":"Ursodeoxycholic Acid",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M7464",
                "InterventionBrowseLeafName":"Gastrointestinal Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Gast",
                "InterventionBrowseBranchName":"Gastrointestinal Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008103",
                "ConditionMeshTerm":"Liver Cirrhosis"
              },{
                "ConditionMeshId":"D000008105",
                "ConditionMeshTerm":"Liver Cirrhosis, Biliary"
              },{
                "ConditionMeshId":"D000005355",
                "ConditionMeshTerm":"Fibrosis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000008107",
                "ConditionAncestorTerm":"Liver Diseases"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              },{
                "ConditionAncestorId":"D000002780",
                "ConditionAncestorTerm":"Cholestasis, Intrahepatic"
              },{
                "ConditionAncestorId":"D000002779",
                "ConditionAncestorTerm":"Cholestasis"
              },{
                "ConditionAncestorId":"D000001649",
                "ConditionAncestorTerm":"Bile Duct Diseases"
              },{
                "ConditionAncestorId":"D000001660",
                "ConditionAncestorTerm":"Biliary Tract Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9686",
                "ConditionBrowseLeafName":"Liver Cirrhosis",
                "ConditionBrowseLeafAsFound":"Cirrhosis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9688",
                "ConditionBrowseLeafName":"Liver Cirrhosis, Biliary",
                "ConditionBrowseLeafAsFound":"Primary Biliary Cirrhosis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M7068",
                "ConditionBrowseLeafName":"Fibrosis",
                "ConditionBrowseLeafAsFound":"Cirrhosis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9690",
                "ConditionBrowseLeafName":"Liver Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7466",
                "ConditionBrowseLeafName":"Gastrointestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5838",
                "ConditionBrowseLeafName":"Digestive System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4602",
                "ConditionBrowseLeafName":"Cholestasis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4603",
                "ConditionBrowseLeafName":"Cholestasis, Intrahepatic",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3516",
                "ConditionBrowseLeafName":"Bile Duct Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3527",
                "ConditionBrowseLeafName":"Biliary Tract Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"T4710",
                "ConditionBrowseLeafName":"Primary Biliary Cholangitis",
                "ConditionBrowseLeafAsFound":"Primary Biliary Cirrhosis",
                "ConditionBrowseLeafRelevance":"high"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"Rare",
                "ConditionBrowseBranchName":"Rare Diseases"
              }
            ]
          }
        }
      }
    }
  }
}