Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT00318305
Status:
COMPLETED
Last Update Posted:
2009-12-02
First Post:
2006-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Patient Preference With Visicol Tablet Preparation for Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-01', 'studyFirstSubmitDate': '2006-04-24', 'studyFirstSubmitQcDate': '2006-04-24', 'lastUpdatePostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Preparation for Colonoscopy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine patient preference and acceptance of tablet sodium phosphate bowel preparation in patients who had polyethylene glycol (PEG) solution for their prior colonoscopy. This study will provide answers related to the patient preferences and their acceptance of this new method of bowel preparation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Scheduled colonoscopy list will be reviewed to identify potential subjects for recruitment. A cover letter will be sent to the potential study subject with tablet preparation as an alternative to Golytely preparation ( PEG). For subjects who are willing to participate, a prescription for 28 tablet sodium phosphate bowel preparation as outlined in appendix: A will be mailed. A questionnaire will be given to the patients prior to their colonoscopy to identify their preferences regarding bowel preparation and their acceptance ( see appendix: B).\n\nA separate validated questionnaire will be given to participating physicians after the procedure, to quantitate the colonic cleansing (appendix : C). Adverse events will be documented. A statistical analysis of the results will be done at the end of the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prior colonoscopy with PEG solution in the past one year\n* Must be able to swallow tablets\n\nExclusion Criteria:\n\n* Patients below 18 years and above 100 years.\n* Congestive heart failure\n* Chronic renal failure\n* Pre-existing electrolyte disorder\n* Pre-existing mega-colon or a motility disorder.\n* Patients with pre-existing seizure disorder.\n* Patients scheduled for colonoscopy after 1:00 p.m. will be excluded from the study.\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT00318305', 'briefTitle': 'Patient Preference With Visicol Tablet Preparation for Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Patient Preference and Acceptance With Sodium Phosphate Tablet Preparation for Colonoscopy: A Prospective Study', 'orgStudyIdInfo': {'id': '392-05'}}, 'contactsLocationsModule': {'locations': [{'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}], 'overallOfficials': [{'name': 'Suryakanth R. Gurudu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'InKine Pharmaceutical', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Suryakanth Gurudu, MD', 'oldOrganization': 'Mayo Clinic'}}}}