{
  "FullStudy":{
    "Rank":218072,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513096",
          "OrgStudyIdInfo":{
            "OrgStudyId":"GI-201201"
          },
          "Organization":{
            "OrgFullName":"Inje University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation",
          "OfficialTitle":"Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation: A Randomized, Controlled Trial",
          "Acronym":"PSPEG"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 30, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 3, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Eun Hee Seo, MD",
            "ResponsiblePartyInvestigatorTitle":"Professor",
            "ResponsiblePartyInvestigatorAffiliation":"Inje University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Inje University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included in a few studies. The investigators study was to show that sufficient dosage of prokinetics added to split dose of PEG improves the state of bowel preparation.",
          "DetailedDescription":"This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy of prokinetics coadministrated with split dose PEG on the bowel cleansing was inspected.\n\nEndoscopists, who were blinded to the study group of the patient, immediately completed the Ottawa scale and the fluidity scale after procedure"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Colonoscopy",
              "Bowel Preparation"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "colonoscopy",
              "bowel preparation",
              "PEG",
              "Prokinetics"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Diagnostic",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"152",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Split-dose PEG",
                "ArmGroupType":"No Intervention",
                "ArmGroupDescription":"Bowel preparation using split dose PEG without prokinetics"
              },{
                "ArmGroupLabel":"Split dose PEG with prokinetics",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Bowel preparation using split-dose PEG with prokinetics",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: itopride"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"itopride",
                "InterventionDescription":"itopride, 10mg, twice per day, for 1 day",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Split dose PEG with prokinetics"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"bowel cleaning quality according to Ottawa scale scores",
                "PrimaryOutcomeTimeFrame":"3 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"procedure time and polyp detection rate",
                "SecondaryOutcomeDescription":"cecal intubation time, polyp detection rate, degree of patient discomfort",
                "SecondaryOutcomeTimeFrame":"3 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatient who are scheduled for colonoscopy\n\nExclusion Criteria:\n\npregnancy,\nbreast feeding,\nknown or suspected bowel obstruction, and\nknown allergy to PEG or Itopride ,\npresence of severe illness(renal failure, congestive heart failure, liver failure,), and\nrefusal of consent to participate in the study",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"80 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Haeundae Paik Hospital, Inje University School of Medicine",
                "LocationCity":"Busan",
                "LocationZip":"612-030",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        }
      }
    }
  }
}