{
  "FullStudy":{
    "Rank":217575,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519609",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Randers-Moviprep"
          },
          "Organization":{
            "OrgFullName":"Randers Regional Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Trial Comparing Moviprep and Phosphoral as Bowel Prep Before Colonoscopy",
          "OfficialTitle":"Double Blind Randomised Trial Comparing Moviprep and Phosphoral as Bowel Prep Before"
        },
        "StatusModule":{
          "StatusVerifiedDate":"November 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"November 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"September 16, 2011",
          "StudyFirstSubmitQCDate":"January 26, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 27, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"November 20, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 21, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Thorbjorn Sommer",
            "ResponsiblePartyInvestigatorTitle":"M.D, Ph.D Associate Professor",
            "ResponsiblePartyInvestigatorAffiliation":"Randers Regional Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Randers Regional Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Using Moviprep patients use shorter time to do a bowel prep before colonoscopy. No major single center has docuemted the advantage of using moviprep as bowel prep before colonoscopy.This randomised study was conducted to compare moviprep with the present standard: Phosphoral to investigate the degree of bowel cleasing before colonoscopy in patients suspected of colorectal cancer, and to investigate number of days where patients need to stay home."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Colorectal Cancer"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Bowel prep",
              "Safety",
              "Efficacy"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"400",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Moviprep",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Moviprep bowel preb",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: bowel prep before endoscopy"
                  ]
                }
              },{
                "ArmGroupLabel":"Phosphoral",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Bowel prep",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: bowel prep before endoscopy"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"bowel prep before endoscopy",
                "InterventionDescription":"bowel prep before colonoscopy",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Moviprep",
                    "Phosphoral"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Degree of bowel cleansing",
                "PrimaryOutcomeDescription":"Will be estimated by the patients and the colonoscopist",
                "PrimaryOutcomeTimeFrame":"1 Day of colonoscopy"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients suspected of colorectal cancer scheduled for colonoscopy\n\nExclusion Criteria:\n\nPatients with previous colorectal surgery\nColonis Stenosis\nASA > 2",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"thorbjorn sommer, ph.D",
                "OverallOfficialAffiliation":"unaffilated",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Randers Regions Hospital",
                "LocationCity":"Randers",
                "LocationZip":"8970",
                "LocationCountry":"Denmark"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000015179",
                "ConditionMeshTerm":"Colorectal Neoplasms"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000007414",
                "ConditionAncestorTerm":"Intestinal Neoplasms"
              },{
                "ConditionAncestorId":"D000005770",
                "ConditionAncestorTerm":"Gastrointestinal Neoplasms"
              },{
                "ConditionAncestorId":"D000004067",
                "ConditionAncestorTerm":"Digestive System Neoplasms"
              },{
                "ConditionAncestorId":"D000009371",
                "ConditionAncestorTerm":"Neoplasms by Site"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              },{
                "ConditionAncestorId":"D000005767",
                "ConditionAncestorTerm":"Gastrointestinal Diseases"
              },{
                "ConditionAncestorId":"D000003108",
                "ConditionAncestorTerm":"Colonic Diseases"
              },{
                "ConditionAncestorId":"D000007410",
                "ConditionAncestorTerm":"Intestinal Diseases"
              },{
                "ConditionAncestorId":"D000012002",
                "ConditionAncestorTerm":"Rectal Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M16473",
                "ConditionBrowseLeafName":"Colorectal Neoplasms",
                "ConditionBrowseLeafAsFound":"Colorectal Cancer",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9031",
                "ConditionBrowseLeafName":"Intestinal Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7469",
                "ConditionBrowseLeafName":"Gastrointestinal Neoplasms",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5839",
                "ConditionBrowseLeafName":"Digestive System Neoplasms",
                "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":"M13427",
                "ConditionBrowseLeafName":"Rectal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}

