{
  "FullStudy":{
    "Rank":217729,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517594",
          "OrgStudyIdInfo":{
            "OrgStudyId":"000026"
          },
          "Organization":{
            "OrgFullName":"Ferring Pharmaceuticals",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Tolerability of Pentasa Sachet in Patients With Ulcerative Colitis",
          "OfficialTitle":"Tolerability of Pentasa® Sachet in Patients With Ulcerative Colitis Under Conditions of Standard Practice in the Czech Republic"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2013",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"October 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"June 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 20, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 18, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 21, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Ferring Pharmaceuticals",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Confirmation of safety profile"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Ulcerative Colitis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"568",
            "EnrollmentType":"Actual"
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"verify the safety profile: measured by number of AEs/SAEs",
                "PrimaryOutcomeTimeFrame":"12 months from patient recruitment"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"dosage: evaluate dosage level",
                "SecondaryOutcomeTimeFrame":"12 months from patient recruitment"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\ntreatment of Ulcerative Colitis\n\nExclusion Criteria:\n\nhypersensitivity to mesalazine\nsevere liver or renal impairment",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Primary care clinic",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Clinical Development Support",
                "OverallOfficialAffiliation":"Ferring Pharmaceuticals",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"FN sv.Anna",
                "LocationCity":"Brno",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Gastroenterologická ambulance",
                "LocationCity":"Brno",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Hospital Milosrdných bratří",
                "LocationCity":"Brno",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Hospital Břeclav",
                "LocationCity":"Břeclav",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Nemocnice Cheb",
                "LocationCity":"Cheb",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Gastroenterologická ambulance Hodonín",
                "LocationCity":"Hodonín",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Hospital TGM Hodonín",
                "LocationCity":"Hodonín",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"FN, II. Interní klinika",
                "LocationCity":"Hradec Králové",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Oblastní nemoncice Jičín",
                "LocationCity":"Jičín",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Nemocnice Karlovy Vary",
                "LocationCity":"Karlovy Vary",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Nemocnice s poliklinikou Ráj",
                "LocationCity":"Karviná",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Gastroenterologická ambulance Jezuitská",
                "LocationCity":"Litoměřice",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Gastroenterologická ambulance Litoměřice",
                "LocationCity":"Litoměřice",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"GASTRO MED, s.r.o.",
                "LocationCity":"Ostrava",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Gastromedic s.r.o.",
                "LocationCity":"Pardubice",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"4. poliklinika Plzeň, Gastroenterologická ambulance",
                "LocationCity":"Plzeň",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Poliklinika - gastroenterologie",
                "LocationCity":"Praha 1",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Fakultní poliklinika VFN",
                "LocationCity":"Praha 2",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Sanatorium sv. Anny",
                "LocationCity":"Praha 3",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"FN Motol",
                "LocationCity":"Praha 5",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Iscare",
                "LocationCity":"Praha 7",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Poliklinika Clinicum - Interna",
                "LocationCity":"Praha 9",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Ústřední vojenská nemocnice",
                "LocationCity":"Praha",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Hospital Prostějov",
                "LocationCity":"Prostějov",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Poliklinika Mens",
                "LocationCity":"Přerov",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Poliklinika - gastroenterologie Rychnov nad Kněžnou",
                "LocationCity":"Rychnov nad Kněžnou",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Nemocnice Valašské Meziříčí",
                "LocationCity":"Valašské Meziříčí",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Vítkovická nemocnice",
                "LocationCity":"Vítkovice",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Krajská nemocnice T.Bati",
                "LocationCity":"Zlín",
                "LocationCountry":"Czech Republic"
              },{
                "LocationFacility":"Masarykova nemocnice,Interna",
                "LocationCity":"Ústí nad labem",
                "LocationCountry":"Czech Republic"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000003092",
                "ConditionMeshTerm":"Colitis"
              },{
                "ConditionMeshId":"D000003093",
                "ConditionMeshTerm":"Colitis, Ulcerative"
              },{
                "ConditionMeshId":"D000014456",
                "ConditionMeshTerm":"Ulcer"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000005759",
                "ConditionAncestorTerm":"Gastroenteritis"
              },{
                "ConditionAncestorId":"D000005767",
                "ConditionAncestorTerm":"Gastrointestinal Diseases"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              },{
                "ConditionAncestorId":"D000003108",
                "ConditionAncestorTerm":"Colonic Diseases"
              },{
                "ConditionAncestorId":"D000007410",
                "ConditionAncestorTerm":"Intestinal Diseases"
              },{
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000015212",
                "ConditionAncestorTerm":"Inflammatory Bowel Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M4903",
                "ConditionBrowseLeafName":"Colitis",
                "ConditionBrowseLeafAsFound":"Colitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M4904",
                "ConditionBrowseLeafName":"Colitis, Ulcerative",
                "ConditionBrowseLeafAsFound":"Ulcerative Colitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M15789",
                "ConditionBrowseLeafName":"Ulcer",
                "ConditionBrowseLeafAsFound":"Ulcerative",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M7458",
                "ConditionBrowseLeafName":"Gastroenteritis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7466",
                "ConditionBrowseLeafName":"Gastrointestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5838",
                "ConditionBrowseLeafName":"Digestive System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4919",
                "ConditionBrowseLeafName":"Colonic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9027",
                "ConditionBrowseLeafName":"Intestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16500",
                "ConditionBrowseLeafName":"Inflammatory Bowel Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}