Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT04758156
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2021-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003111', 'term': 'Colonic Polyps'}], 'ancestors': [{'id': 'D007417', 'term': 'Intestinal Polyps'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-04', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-02-16', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Boston Bowel Preparation Scale (BBPS)', 'timeFrame': 'at the time of colonoscopy procedure', 'description': 'Bowel cleansing score'}], 'secondaryOutcomes': [{'measure': 'questionnaire gathered for Tolerability, compliance, satisfaction', 'timeFrame': 'on the 1 day of colonoscopy via questionnaire', 'description': 'information gathered via questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colon Adenoma', 'Colonic Polyp']}, 'descriptionModule': {'briefSummary': 'Comparison between a 1L of polyethylene glycol+ascorbic acid as a split dose and oral sulfate solution bowel preparation for colonoscopy\n\nstudy design: prospective, randomized, parallel, multi-center trial in 3 hospitals in Korea ( Seoul National University hospital, Seoul National University Bundang hospital, Seoul Metropolitan Government-Seoul National University )\n\npatient inclusion criteria\n\n\\- aged 20-75 adults (out-clinic patients) scheduled for colonoscopy for any indication within the normal process of care'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult out clinic patients scheduled for colonoscopy for any indication within the normal process of care\n\nExclusion Criteria:\n\n* previous history of significant gastrointestinal surgeries (except for appendectomy)\n* known or clinically suspicious Inflammatory bowel disease patients\n* known or suspected ileus/ GI obstruction\n* previous history of major cancer or currently on treating cancer\n* Major cardiovascular disease, respiratory disease, liver, hematologic diseases with complication\n* severe cognitive impairment / dementia / confusion state\n* past history within the last 12 months or current episode of severe constipation severe constipation\n* Regular use of laxatives or colon motility-altering drugs (i. e. more than 2 - 3 times per week) in the last 28 days prior to screening and/or laxative use within 72 hours prior to administration of the preparation)\n* women who are pregnant or lactating\n* known phenylketonuria, glucose-6-phosphate dehydrogenase deficiency\n* those who were allergic to any preparation components.\n* those who, in the opinion of the investigator, should not be included in the study for any reason'}, 'identificationModule': {'nctId': 'NCT04758156', 'briefTitle': 'Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison Between a 1L of Polyethylene Glycol+Ascorbic Acid as a Split Dose Bowel Preparation for Colonoscopy: Prospective, Randomized, Parallel, Multi-center Trial', 'orgStudyIdInfo': {'id': '1905-1831'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CleanViewAL', 'description': '1L polyethylene glycol+ascorbic acid split dose', 'interventionNames': ['Drug: CleanViewAL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'SUPREP', 'description': 'Oral sulfate solutiom', 'interventionNames': ['Drug: SUPREP']}], 'interventions': [{'name': 'CleanViewAL', 'type': 'DRUG', 'description': '1L PEG + ascorbic acid bowel preparation for colonoscopy', 'armGroupLabels': ['CleanViewAL']}, {'name': 'SUPREP', 'type': 'DRUG', 'description': 'Oral sulfate solution for colonoscopy bowel preparation', 'armGroupLabels': ['SUPREP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyun Jung Lee, MD, PhD', 'role': 'CONTACT', 'email': 'guswjd80@gmail.com', 'phone': '+82-2-740-3439'}], 'facility': 'Seoul national university hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Hyun Jung Lee, MD, PhD', 'role': 'CONTACT', 'email': 'guswjd80@gmail.com', 'phone': '+82-2-740-3439'}], 'overallOfficials': [{'name': 'Jong Pil Im, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, MD, PhD', 'investigatorFullName': 'Hyun Jung Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}