Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-02-25 @ 8:52 PM
Study NCT ID:
NCT01398020
Status:
COMPLETED
Last Update Posted:
2013-09-19
First Post:
2011-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing 2L Bi-Pegyte to 4L PegLyte Regiments for Outpatient Colonic Preparation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-17', 'studyFirstSubmitDate': '2011-07-14', 'studyFirstSubmitQcDate': '2011-07-18', 'lastUpdatePostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Boston Bowel Preparation Scale between the two groups', 'timeFrame': '30 minutes', 'description': 'This is an established rating scale to evaluate the quality of bowel prep. The ratings will be compared between the two groups.'}], 'secondaryOutcomes': [{'measure': 'Difference in the number of participants who develop distress symptoms from bowel prep (and the type) between the two groups', 'timeFrame': '20 hours', 'description': 'Number of participants who develop distress symptoms from bowel prep, and the type of distress symptoms will be compared between the two groups'}, {'measure': 'Difference in the absolute number/percentage of participants in the two groups who find the bowel prep experience easy, acceptable, difficult, very difficult, or unable to complete.', 'timeFrame': '20', 'description': 'Participants will be asked to rate their bowel prep experience (based on ease of use) on a Likert scale. The number of participants in each level will subsequently be quantified (n, %) and compared between the two groups.'}]}, 'conditionsModule': {'keywords': ['Bowel Preparation', 'Patient comfort', 'Bi-Peglyte'], 'conditions': ['Efficacy of Bowel Preparation', 'Ease of Bowel Preparation and Patient Tolerability']}, 'descriptionModule': {'briefSummary': 'The investigators wish to compare the efficacy and patient tolerability of a preparation consisting of 2L Bi-Peglyte plus 15mg of bisacodyl vs the standard preparation of 4L Peglyte. The investigators hypothesize that 2L Bi-Peglyte with 15mg bisacodyl will show higher efficacy and tolerability.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 19 or older\n* Outpatient colonoscopy\n\nExclusion Criteria:\n\n* constipation'}, 'identificationModule': {'nctId': 'NCT01398020', 'briefTitle': 'Comparing 2L Bi-Pegyte to 4L PegLyte Regiments for Outpatient Colonic Preparation', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Oral 2L Bi-PegLyte Versus 4L PegLyte Regimen for Outpatient Colonic Preparation: A Randomized, Non-Inferiority Open Trial', 'orgStudyIdInfo': {'id': 'H11-00688'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard bowel prep', 'description': 'Subject will receive standard bowel prep prior to colonoscopy.', 'interventionNames': ['Drug: Standard Bowel Prep']}, {'type': 'EXPERIMENTAL', 'label': '2L Bi-Peglyte', 'description': 'Subjects will be asked to take 2L Bi-Peglyte + 15mg bisacodyl for bowel prep the day before colonoscopy.', 'interventionNames': ['Drug: 2L Bi-Peglyte Bowel Prep']}], 'interventions': [{'name': 'Standard Bowel Prep', 'type': 'DRUG', 'description': 'Subjects will be asked to take 4L of Peglyte the day prior to procedure.', 'armGroupLabels': ['Standard bowel prep']}, {'name': '2L Bi-Peglyte Bowel Prep', 'type': 'DRUG', 'description': 'Subjects will be asked to take 2L Bi-Peglyte and 15mg bisacodyl the day prior to procedure.', 'armGroupLabels': ['2L Bi-Peglyte']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V6Z1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Robert A Enns, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of British Columbia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}