Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT02956057
Status:
COMPLETED
Last Update Posted:
2020-10-28
First Post:
2016-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'id': 'C110422', 'term': 'magnesium citrate'}, {'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D005026', 'term': 'Ethylene Glycols'}, {'id': 'D006018', 'term': 'Glycols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kojecky@bnzlin.cz', 'phone': '+420577552512', 'title': 'Kojecky Vladimir', 'organization': 'Tomas Bata Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '0', 'description': 'AE not assessed', 'eventGroups': [{'id': 'EG000', 'title': 'PEG1D', 'description': 'Polyethylene glycols single dose a day before colonoscopy', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PEG2D', 'description': 'Polyethylene glycols split dose', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SPMC1D', 'description': 'Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'SPMC2D', 'description': 'Natrium picosulfate/ Magnesium citrate split dose', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'PEGA1D', 'description': 'Polyethylene glycol / Ascorbic acid single dose day before colonoscopy', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'PEGA2D', 'description': 'Polyethylene glycol / Ascorbic acid split dose', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '159', 'groupId': 'OG003'}, {'value': '169', 'groupId': 'OG004'}, {'value': '157', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PEG1D', 'description': 'Polyethylene glycols single dose a day before colonoscopy'}, {'id': 'OG001', 'title': 'PEG2D', 'description': 'Polyethylene glycols split dose'}, {'id': 'OG002', 'title': 'SPMC1D', 'description': 'Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy'}, {'id': 'OG003', 'title': 'SPMC2D', 'description': 'Natrium picosulfate/ Magnesium citrate split dose'}, {'id': 'OG004', 'title': 'PEGA1D', 'description': 'Polyethylene glycol / Ascorbic acid single dose day before colonoscopy'}, {'id': 'OG005', 'title': 'PEGA2D', 'description': 'Polyethylene glycol / Ascorbic acid split dose'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '100', 'groupId': 'OG002'}, {'value': '134', 'groupId': 'OG003'}, {'value': '121', 'groupId': 'OG004'}, {'value': '55', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One day', 'description': 'Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '159', 'groupId': 'OG003'}, {'value': '169', 'groupId': 'OG004'}, {'value': '157', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'PEG1D', 'description': 'Polyethylene glycols single dose a day before colonoscopy'}, {'id': 'OG001', 'title': 'PEG2D', 'description': 'Polyethylene glycols split dose'}, {'id': 'OG002', 'title': 'SPMC1D', 'description': 'Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy'}, {'id': 'OG003', 'title': 'SPMC2D', 'description': 'Natrium picosulfate/ Magnesium citrate split dose'}, {'id': 'OG004', 'title': 'PEGA1D', 'description': 'Polyethylene glycol / Ascorbic acid single dose day before colonoscopy'}, {'id': 'OG005', 'title': 'PEGA2D', 'description': 'Polyethylene glycol / Ascorbic acid split dose'}], 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '134', 'groupId': 'OG002'}, {'value': '139', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}, {'value': '80', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One day', 'description': 'Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PEG1D', 'description': 'Polyethylene glycols single dose a day before colonoscopy\n\nPolyethylene Glycols'}, {'id': 'FG001', 'title': 'PEG2D', 'description': 'Polyethylene glycols split dose\n\nPolyethylene Glycols'}, {'id': 'FG002', 'title': 'SPMC1D', 'description': 'Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy\n\nNatrium picosulfate / Magnesium citrate'}, {'id': 'FG003', 'title': 'SPMC2D', 'description': 'Natrium picosulfate/ Magnesium citrate split dose\n\nNatrium picosulfate / Magnesium citrate'}, {'id': 'FG004', 'title': 'PEGA1D', 'description': 'Polyethylene glycol / Ascorbic acid single dose day before colonoscopy\n\nPolyethylene glycol / Ascorbic acid'}, {'id': 'FG005', 'title': 'PEGA2D', 'description': 'Polyethylene glycol / Ascorbic acid split dose\n\nPolyethylene glycol / Ascorbic acid'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '174'}, {'groupId': 'FG001', 'numSubjects': '174'}, {'groupId': 'FG002', 'numSubjects': '174'}, {'groupId': 'FG003', 'numSubjects': '174'}, {'groupId': 'FG004', 'numSubjects': '174'}, {'groupId': 'FG005', 'numSubjects': '174'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '160'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '166'}, {'groupId': 'FG003', 'numSubjects': '159'}, {'groupId': 'FG004', 'numSubjects': '169'}, {'groupId': 'FG005', 'numSubjects': '157'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Discontinued intervention', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '14'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '17'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}, {'value': '169', 'groupId': 'BG004'}, {'value': '157', 'groupId': 'BG005'}, {'value': '973', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'PEG1D', 'description': 'Polyethylene glycols single dose a day before colonoscopy'}, {'id': 'BG001', 'title': 'PEG2D', 'description': 'Polyethylene glycols split dose'}, {'id': 'BG002', 'title': 'SPMC1D', 'description': 'Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy'}, {'id': 'BG003', 'title': 'SPMC2D', 'description': 'Natrium picosulfate/ Magnesium citrate split dose'}, {'id': 'BG004', 'title': 'PEGA1D', 'description': 'Polyethylene glycol / Ascorbic acid single dose day before colonoscopy'}, {'id': 'BG005', 'title': 'PEGA2D', 'description': 'Polyethylene glycol / Ascorbic acid split dose'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.9', 'spread': '15.3', 'groupId': 'BG000'}, {'value': '64.5', 'spread': '13.9', 'groupId': 'BG001'}, {'value': '60.8', 'spread': '16.1', 'groupId': 'BG002'}, {'value': '63.1', 'spread': '13.1', 'groupId': 'BG003'}, {'value': '60.1', 'spread': '14.3', 'groupId': 'BG004'}, {'value': '60.6', 'spread': '17.0', 'groupId': 'BG005'}, {'value': '62.1', 'spread': '14.2', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}, {'value': '67', 'groupId': 'BG005'}, {'value': '429', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}, {'value': '82', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '90', 'groupId': 'BG005'}, {'value': '544', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}, {'value': '169', 'groupId': 'BG004'}, {'value': '157', 'groupId': 'BG005'}, {'value': '973', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Czechia', 'categories': [{'measurements': [{'value': '160', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '166', 'groupId': 'BG002'}, {'value': '159', 'groupId': 'BG003'}, {'value': '169', 'groupId': 'BG004'}, {'value': '157', 'groupId': 'BG005'}, {'value': '973', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-01-03', 'size': 115471, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-10-06T16:21', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1044}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2017-08-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-06', 'studyFirstSubmitDate': '2016-11-01', 'resultsFirstSubmitDate': '2019-10-06', 'studyFirstSubmitQcDate': '2016-11-03', 'lastUpdatePostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-10-06', 'studyFirstPostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Bowel Preparation Using the Aronchick Scale ( Score 1+2)', 'timeFrame': 'One day', 'description': 'Bowel preparation score 1+2 expressed on Aronchick scale (1 the best, 5 the worst)'}], 'secondaryOutcomes': [{'measure': 'Tolerance of Bowel Preparation Assessed by 5 Point VAS ( Score 1+2)', 'timeFrame': 'One day', 'description': 'Tolerance of Bowel Preparation Assessed by VAS score 1+2 ( 1-excellent, 5-very poor)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Colonoscopy']}, 'referencesModule': {'references': [{'pmid': '28944412', 'type': 'BACKGROUND', 'citation': 'Kojecky V, Matous J, Keil R, Dastych M, Kroupa R, Zadorova Z, Varga M, Dolina J, Kment M, Hep A. A head-to-head comparison of 4-L polyethylene glycol and low-volume solutions before colonoscopy: which is the best? A multicentre, randomized trial. Int J Colorectal Dis. 2017 Dec;32(12):1763-1766. doi: 10.1007/s00384-017-2901-x. Epub 2017 Sep 24.'}]}, 'descriptionModule': {'briefSummary': 'Study evaluates the efficacy and tolerability of low volume preparations compared with conventional 4L polyethylene glycol prior to colonoscopy', 'detailedDescription': 'To compare the efficacy and tolerance of standard polyethylene glycol to low volume sodium picosulphate/magnesium citrate and polyethylene glycol/ascorbic acid in a single or split dose regimen for colonoscopy bowel preparation in a head-to-head design.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects referred to diagnostic or therapeutic colonoscopy\n\nExclusion Criteria:\n\n* ileus\n* known or suspected bowel obstruction\n* active bowel inflammation\n* pregnancy\n* any presence of serious medical conditions\n* history of prior colonic or rectal surgery\n* inability to obtain valid data from subject'}, 'identificationModule': {'nctId': 'NCT02956057', 'briefTitle': 'Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Tomas Bata Hospital, Czech Republic'}, 'officialTitle': 'A Head-to-head Comparison of Efficiency and Tolerance of 4-L Polyethylene Glycol and Sodium Picosulphate/ Magnesium Citrate, Polyethylene Glycol/Ascorbate Before Colonoscopy', 'orgStudyIdInfo': {'id': 'BN102016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'PEG1D', 'description': 'Polyethylene glycols single dose a day before colonoscopy', 'interventionNames': ['Drug: Polyethylene Glycols']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PEG2D', 'description': 'Polyethylene glycols split dose', 'interventionNames': ['Drug: Polyethylene Glycols']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SPMC1D', 'description': 'Natrium picosulfate/ Magnesium citrate single dose day before colonoscopy', 'interventionNames': ['Drug: Natrium picosulfate / Magnesium citrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'SPMC2D', 'description': 'Natrium picosulfate/ Magnesium citrate split dose', 'interventionNames': ['Drug: Natrium picosulfate / Magnesium citrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PEGA1D', 'description': 'Polyethylene glycol / Ascorbic acid single dose day before colonoscopy', 'interventionNames': ['Drug: Polyethylene glycol / Ascorbic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PEGA2D', 'description': 'Polyethylene glycol / Ascorbic acid split dose', 'interventionNames': ['Drug: Polyethylene glycol / Ascorbic acid']}], 'interventions': [{'name': 'Polyethylene Glycols', 'type': 'DRUG', 'armGroupLabels': ['PEG1D', 'PEG2D']}, {'name': 'Natrium picosulfate / Magnesium citrate', 'type': 'DRUG', 'armGroupLabels': ['SPMC1D', 'SPMC2D']}, {'name': 'Polyethylene glycol / Ascorbic acid', 'type': 'DRUG', 'armGroupLabels': ['PEGA1D', 'PEGA2D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10024', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Faculty Hospital Kralovske Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'overallOfficials': [{'name': 'Vladimir Kojecky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nemocnice T.Bati'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tomas Bata Hospital, Czech Republic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Brno University Hospital', 'class': 'OTHER'}, {'name': 'Faculty Hospital Kralovske Vinohrady', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MUDr.', 'investigatorFullName': 'Vladimir Kojecky, MD, Ph.D.', 'investigatorAffiliation': 'Tomas Bata Hospital, Czech Republic'}}}}