Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT00278967
Status:
COMPLETED
Last Update Posted:
2006-10-19
First Post:
2006-01-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001726', 'term': 'Bisacodyl'}], 'ancestors': [{'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2006-08'}, 'lastUpdateSubmitDate': '2006-10-18', 'studyFirstSubmitDate': '2006-01-13', 'studyFirstSubmitQcDate': '2006-01-13', 'lastUpdatePostDateStruct': {'date': '2006-10-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy - preparation quality using a 4-point scale'}], 'secondaryOutcomes': [{'measure': 'Safety - patient-reported preparation related side-effects'}]}, 'conditionsModule': {'keywords': ['colonoscopy', 'preparation'], 'conditions': ['Colonoscopy']}, 'descriptionModule': {'briefSummary': 'To compare the safety and efficacy of 2 different bowel cleansing preparations prior to colonoscopy in adult subjects.', 'detailedDescription': 'The goal of the study is to evaluate the efficacy of 2 different HalfLytely preparations to produce a clinically acceptable degree of cleansing of the bowel, sufficient for colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n\\- Male or female outpatients who are undergoing colonoscopy for the following routinely accepted indications:\n\nEvaluation of BE results GI bleeding Anemia of unknown etiology Neoplastic disease surveillance Endosonography Inflammatory bowel disease Unknown diarrhea or constipation etiology Polypectomy Laser therapy Routine Screening\n\n* At least 18 years of age\n* Otherwise in good health, as determined by physical exam and medical history\n* If female, and of child-bearing potential, is using an acceptable form of birth control (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)\n* Negative urine pregnancy test at screening, if applicable\n* In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study\n\nExclusion Criteria:\n\n* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, or toxic megacolon\n* Subjects with impaired consciousness that predisposes them to pulmonary aspiration\n* Subjects who are undergoing colonoscopy for foreign body removal and decompression\n* Subjects with pre-existing electrolyte disturbances, such as dehydration, or those secondary to the use of diuretics\n* Subjects who are taking drugs that may affect electrolyte levels\n* Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments for the duration of the study\n* Subjects with known clinically significant electrolyte abnormalities such as hypernatremia, hyperphosphatemia, hypokalemia, or hypocalcemia\n* Subjects who are pregnant or lactating, or intending to become pregnant during the study\n* Subjects of childbearing potential who refuse a pregnancy test\n* Subjects who are allergic to any preparation components\n* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures\n* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days"}, 'identificationModule': {'nctId': 'NCT00278967', 'briefTitle': 'An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Braintree Laboratories'}, 'officialTitle': 'An Efficacy Evaluation of 2 Different Bowel Cleansing Preparations in Adult Subjects', 'orgStudyIdInfo': {'id': 'F38-26'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HalfLytely with Bisacodyl Tablets Bowel Prep Kit', 'type': 'DRUG'}, {'name': 'HalfLytely - Reformulation', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '33458', 'city': 'Jupiter', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.93422, 'lon': -80.09421}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '20707', 'city': 'Laurel', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.09928, 'lon': -76.84831}}, {'zip': '11023', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '98004', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '99207', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Michael Goldstein, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Long Island GI Research Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Braintree Laboratories', 'class': 'INDUSTRY'}}}}