{
  "FullStudy":{
    "Rank":217638,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518790",
          "OrgStudyIdInfo":{
            "OrgStudyId":"353750"
          },
          "Organization":{
            "OrgFullName":"Walter Reed National Military Medical Center",
            "OrgClass":"FED"
          },
          "BriefTitle":"Short Course, Single-dose PEG 3350 for Colonoscopy Prep in Children",
          "OfficialTitle":"Evaluation of Short Course, Single-dose Polyethylene Glycol (PEG) 3350 Regimen for Colonoscopy Bowel Preparation in Children"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2011",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2011",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 9, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 10, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Walter Reed National Military Medical Center",
            "LeadSponsorClass":"FED"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The investigators propose to conduct a prospective study of a widely used bowel preparation regimen (polyethylene glycol 3350 + a sports drink) on pediatric patients who undergo a colonoscopy performed by the pediatric gastroenterology service at WRAMC/WRNMMC between 1 Sep 2010 and 31 Dec 2011. This study will involve the following: determine efficacy of the cleanout, assess tolerability and acceptance of the regimen, determine an appropriate duration to complete the regimen and assess for any electrolyte changes or side effects.",
          "DetailedDescription":"Purpose: It is hoped that by determining acceptability, safety and efficacy of this widely used short course, single-dose bowel preparation regimen, pediatric gastroenterologist can have a standardized bowel preparation for colonoscopy that will be acceptable to pediatric patients and their parents.\n\nResearch Design: This study is a prospective medication trial. It will utilize laboratory data to detect any electrolyte changes, a patient questionnaire to assess an acceptable duration, tolerance and side effects of the regimen. Efficacy of the cleanout will be assessed using a published standardized bowel preparation scale by the endoscopist at the completion of the colonoscopy.\n\nMethodology /Technical Approach (including the number of subjects to be studied.): We estimate that 50 patients aged 8-18 years old military dependents who are undergoing a colonoscopy by the Pediatric Gastroenterology service at WRAMC/WRNMMC will be enrolled in the study between 1 Sep 2010 and 31 Dec 2011."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Colonoscopy"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "PEG 3350",
              "boston bowel preparation scale",
              "colonoscopy cleanout",
              "bowel preparation",
              "miralax",
              "gatorade",
              "cleanout efficacy",
              "Focus of study is efficacy of PEG 3350 cleanout for improving diagnostic yield of colonoscopy."
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Diagnostic",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"50",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Polyethylene glycol 3350",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: polyethylene glycol 3350"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"polyethylene glycol 3350",
                "InterventionDescription":"PEG 3350 (238 grams) mixed with 1.9 L (64 oz) of Gatorade, given in 8 oz increments every 15-30 minutes until complete starting at 18:00 on day prior to colonoscopy (max time to completion 6 hours).",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Polyethylene glycol 3350"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Miralax"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Efficacy of Cleanout",
                "PrimaryOutcomeDescription":"Efficacy of cleanout utilizing Boston bowel preparation scale, completed by endoscopy fellow and staff at the end of the colonoscopy done within 10-18 hours after completion of the cleanout.",
                "PrimaryOutcomeTimeFrame":"At the end of the colonoscopy within 10-18 hours of completing the cleanout"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Electrolyte changes assessing basic metabolic profiles pre/post cleanout",
                "SecondaryOutcomeDescription":"BMP will be obtain within 30 days of cleanout and on the day of the colonoscopy at the time of IV insertion for anesthesia.",
                "SecondaryOutcomeTimeFrame":"30 days prior to 1 day after cleanout"
              },{
                "SecondaryOutcomeMeasure":"Patient/parent satisfaction/tolerability/side effects utilizing questionnaire",
                "SecondaryOutcomeDescription":"Parents or patient fill out questionnaire on day of the colonoscopy",
                "SecondaryOutcomeTimeFrame":"1 day after cleanout"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nMale and female DEERS-eligible dependent military health care beneficiaries age 8 to 18 years old evaluated by Pediatric Gastroenterology service at WRAMC and are scheduled to undergo a colonoscopy between 1 Sep 2010 - 31 Dec 2011 and do not meet exclusion criteria.\n\nExclusion Criteria:\n\nAge less than 8 years or greater than 18 at time of procedure\nColonic surgery including hemicolectomy, colectomy, ileostomy, or multiple abdominal surgeries.\nOral aversion or other feeding disorder.\nInability to drink large amount of liquids.\nAspiration risk.\nRenal disease or pre-cleanout electrolytes outside normal range.\nSignificant cardiovascular disease.\nAllergy to food coloring or polyethylene glycol 3350.\nInpatient or emergency colonoscopy.\nCurrent nasogastric tube in place.\nKnown Pregnancy. Urine pregnancy test will only be completed on day of colonoscopy for all females age 14 and older per current standard anesthesia protocols. There have been no known reported animal or human studies that report the fetal effects of using polyethylene glycol. Per FDA, it is labeled as a category C drug in pregnancy. However, two studies , have reported successful treatment of constipation during pregnancy using polyethylene glycol solutions and did not find any significant effects or safety issues",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"8 Years",
          "MaximumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Mazen I Abbas, DO, MPH",
                "OverallOfficialAffiliation":"Walter Reed National Military Medical Center",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Walter Reed National Military Medical Center",
                "LocationCity":"Bethesda",
                "LocationState":"Maryland",
                "LocationZip":"20814",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"22744195",
                "ReferenceType":"derived",
                "ReferenceCitation":"Abbas MI, Nylund CM, Bruch CJ, Nazareno LG, Rogers PL. Prospective evaluation of 1-day polyethylene glycol-3350 bowel preparation regimen in children. J Pediatr Gastroenterol Nutr. 2013 Feb;56(2):220-4. doi: 10.1097/MPG.0b013e31826630fc."
              }
            ]
          }
        }
      },
      "AnnotationSection":{
        "AnnotationModule":{
          "UnpostedAnnotation":{
            "UnpostedResponsibleParty":"Walter Reed National Military Medical Center",
            "UnpostedEventList":{
              "UnpostedEvent":[
                {
                  "UnpostedEventType":"Release",
                  "UnpostedEventDate":"April 26, 2016"
                },{
                  "UnpostedEventType":"Reset",
                  "UnpostedEventDate":"June 2, 2016"
                },{
                  "UnpostedEventType":"Release",
                  "UnpostedEventDate":"October 31, 2016"
                },{
                  "UnpostedEventType":"Reset",
                  "UnpostedEventDate":"December 22, 2016"
                },{
                  "UnpostedEventType":"Release",
                  "UnpostedEventDate":"May 10, 2017"
                },{
                  "UnpostedEventType":"Reset",
                  "UnpostedEventDate":"June 8, 2017"
                }
              ]
            }
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"C000595212",
                "InterventionMeshTerm":"Polyethylene glycol 3350"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000054368",
                "InterventionAncestorTerm":"Laxatives"
              },{
                "InterventionAncestorId":"D000005765",
                "InterventionAncestorTerm":"Gastrointestinal Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M268015",
                "InterventionBrowseLeafName":"Polyethylene glycol 3350",
                "InterventionBrowseLeafAsFound":"Polyethylene glycol 3350",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M26251",
                "InterventionBrowseLeafName":"Laxatives",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M4234",
                "InterventionBrowseLeafName":"Cathartics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M7464",
                "InterventionBrowseLeafName":"Gastrointestinal Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Gast",
                "InterventionBrowseBranchName":"Gastrointestinal Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        }
      }
    }
  }
}