Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-02-27 @ 1:11 AM
Study NCT ID:
NCT01740518
Status:
UNKNOWN
Last Update Posted:
2012-12-04
First Post:
2012-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011092', 'term': 'Polyethylene Glycols'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'lastUpdateSubmitDate': '2012-11-30', 'studyFirstSubmitDate': '2012-11-30', 'studyFirstSubmitQcDate': '2012-11-30', 'lastUpdatePostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of bowel preparation', 'timeFrame': 'one day (after colonoscopy)', 'description': 'three segmental preparation scoring (0\\~4, Rt., mid, Lt.colon) total preparation grade:A,B,C,D (A or B was defined successful bowel cleansing) Influence of the intake of additional fluid in PEG+ascorbic acid'}], 'secondaryOutcomes': [{'measure': "Patient's compliance and acceptability", 'timeFrame': 'one day (after injestion of preparation solution)', 'description': 'satisfaction (Visual Analogue Scale) amount of ingestion, frequency and amount of vomiting, tolerability, complication, taste'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Colonoscopy [E01.370.372.250.250.200]']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://irb.kbsmc.co.kr', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare two regimens of low volume (2L) polyethylene glycol(PEG)plus ascorbic acid versus standard volume (4L) PEG alone for bowel preparation in out-patients', 'detailedDescription': 'Inadequate bowel preparation may lead to a longer colonoscopy, and to an inability to identify lesions. PEG can provide a rapid orthograde peroral approach to colonic lavage without producing significant fluid or electrolyte changes. Thus PEG is now commonly used for bowel preparation. However, large amounts and unsatisfactory taste of PEG solution are generally poorly tolerated. a new low volume PEG-based bowel cleansing agents became available at foreign countries. Although several studies reported the efficacy and improved compliance of these low volume PEG plus ascorbic acid solution for colonoscopy, but result in Korean patients was not-recognized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Out-patients for colonoscopy in university hospital', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Out-patients for colonoscopy\n\nExclusion Criteria:\n\n* age under 19 years or over 80 years\n* Intestinal obstruction\n* Women of pregnant, breastfeeding, or at risk of becoming pregnant\n* major psychiatric illness\n* known allergy to PEG\n* serious condition- severe cardiac, renal, or metabolic diseases\n* past history of colon resection\n* current acute exacerbation of chronic inflammatory bowel disease\n* functional constipation defined by Rome III diagnostic criteria'}, 'identificationModule': {'nctId': 'NCT01740518', 'briefTitle': 'Comparison of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Kangbuk Samsung Hospital'}, 'officialTitle': 'Randomized Controlled Trial of Low-volume PEG Plus Ascorbic Acid Versus Standard PEG Solution as Bowel Cleansing for Colonoscopy', 'orgStudyIdInfo': {'id': 'ASCPD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PEG + ascorbic acid', 'description': 'Those who taken PEG 2L + ascorbic acid', 'interventionNames': ['Drug: polyethylene glycol, ascorbic acid']}, {'label': 'PEG 4L', 'description': 'Those who taken PEG 4L alone'}], 'interventions': [{'name': 'polyethylene glycol, ascorbic acid', 'type': 'DRUG', 'description': 'comparison of different solutions for bowel preparation', 'armGroupLabels': ['PEG + ascorbic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-746', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dong Il Park, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kangbuk Samsung Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong Il Park, M.D, Ph.D.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Dong Il Park, M.D, Ph.D.', 'investigatorAffiliation': 'Kangbuk Samsung Hospital'}}}}