Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-03-21 @ 7:19 PM
Study NCT ID:
NCT00621920
Status:
COMPLETED
Last Update Posted:
2012-02-10
First Post:
2008-02-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Bowel Preparation Before Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-08', 'studyFirstSubmitDate': '2008-02-12', 'studyFirstSubmitQcDate': '2008-02-21', 'lastUpdatePostDateStruct': {'date': '2012-02-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness of bowel cleansing based on a grading scale.', 'timeFrame': 'During colonoscopy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bowel Cleansing Prior to Colonoscopy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the efficacious dose range when used as a bowel preparation before colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and nonpregnant women who are scheduled for an elective colonoscopy and who are at least 50 years of age.\n* Are able to communicate with study personnel and comply with study requirements.\n* Are able and willing to follow study-specified testing, diet, and hydration regimen.\n* Have been informed of the nature and risks of the study and have given written informed consent.\n\nExclusion Criteria:\n\n* Have known or suspected liver disease or any history of abnormal liver function tests.\n* Have clinically active cardiovascular disease within the past 6 months.\n* Have blood pressure greater than 150/90 mm Hg.\n* Have known or suspected renal insufficiency.\n* Have known or suspected electrolyte abnormalities, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon, or ileus.\n* Have a history of prior bowel surgery within 2 years before enrollment, or active inflammatory bowel disease.\n* Have diabetes or a history of diabetes.\n* Have clinical evidence of dehydration.\n* Are pregnant or breast-feeding.\n* Are unwilling to abstain from alcohol consumption from one day before colonoscopy until discharged from the study.\n* Use prohibited medications of the study in the defined timeframes.\n* Have received any investigational agent within 30 days before dosing.\n* Have any known contraindications to the study treatment.\n* Have any known or suspected allergies to the components of the study medication.\n* Have any other condition which would make the subject unsuitable for inclusion in the study.'}, 'identificationModule': {'nctId': 'NCT00621920', 'briefTitle': 'Efficacy Study of Bowel Preparation Before Colonoscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'C.B. Fleet Company, Inc.'}, 'officialTitle': 'Efficacy Study of Bowel Preparation Before Colonoscopy', 'orgStudyIdInfo': {'id': 'PL07.01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'FM-601', 'type': 'DRUG', 'description': 'Dose-escalation, split dosage, liquid'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Advanced Clinical Research Institute', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '68154', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Qualia Clinical Services', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'C.B. Fleet Company, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}