Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-01 @ 6:34 PM
Study NCT ID:
NCT00425594
Status:
COMPLETED
Last Update Posted:
2007-12-27
First Post:
2007-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001726', 'term': 'Bisacodyl'}, {'id': 'C000595212', 'term': 'polyethylene glycol 3350'}], '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': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-20', 'studyFirstSubmitDate': '2007-01-19', 'studyFirstSubmitQcDate': '2007-01-22', 'lastUpdatePostDateStruct': {'date': '2007-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy - preparation quality using a 4-point scale'}], 'secondaryOutcomes': [{'measure': 'Safety - patient reported preparation related side effects. Pre and post preparation analysis of serum chemistry.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'bowel preparation', 'prep'], 'conditions': ['Colonoscopy']}, 'descriptionModule': {'briefSummary': 'This randomized, parallel, multi-center, single-blind study is designed to compare the safety and efficacy of 3 bowel preparations in pediatric subjects scheduled to undergo a colonoscopy for a routinely accepted indication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female patients who are undergoing colonoscopy for a routinely accepted indication, including:\n\n * Evaluation of BE results\n * Endosonography\n * Blood in stool\n * Anemia of unknown etiology\n * Abdominal Pain\n * Polypectomy\n * Unknown diarrhea or constipation etiology\n * Inflammatory bowel disease\n* Between 6 and 16 years of age at screening.\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, parent/guardian 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 impacted at screening\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 known difficulties for swallowing tablets\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 with the exception of routine diuretics.\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.\n* Any condition in parent/guardian associated with poor subject compliance (e.g., substance abuse); inability of parent/guardian to return for scheduled visits with their child."}, 'identificationModule': {'nctId': 'NCT00425594', 'briefTitle': 'A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population', 'organization': {'class': 'INDUSTRY', 'fullName': 'Braintree Laboratories'}, 'officialTitle': 'A Safety and Efficacy Evaluation of 3 Bowel Preparations in the Pediatric Population', 'orgStudyIdInfo': {'id': 'F38-25'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HalfLytely and Bisacodyl Tablets - Formulation 1', 'type': 'DRUG'}, {'name': 'HalfLytely and Bisacodyl Tablets - Formulation 2', 'type': 'DRUG'}, {'name': 'NuLYTELY', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '35406', 'city': 'Tuscaloosa', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.20984, 'lon': -87.56917}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72202', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32801', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89109', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '14222', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '17604', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '29203', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '84113', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'John McGowan', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Braintree Laboratories, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Braintree Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'John McGowan, Clinical Operations Manager', 'oldOrganization': 'Braintree Laboratories, Inc.'}}}}