Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT06287606
Status:
COMPLETED
Last Update Posted:
2024-11-29
First Post:
2024-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2024-02-23', 'studyFirstSubmitQcDate': '2024-02-23', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Comparison of Acute gastropathy probability score', 'timeFrame': '1 day of scheduled colonoscopy', 'description': "According to 'The Manual of Gastric Mucosal Assessment', it's graded on a scale of 'Possible' to 'Very likely'."}], 'primaryOutcomes': [{'measure': 'Ratio of subjects With successful Bowel Cleansing', 'timeFrame': '1 day of scheduled colonoscopy', 'description': 'The overall quality of bowel cleansing was assessed by a blinded central reader (an experienced and trained colonoscopist) using the segmental scores of the Harefield Cleansing Scale (HCS). A final HCS grading of A, B, C or D was derived. Grades A and B are classified as successful (i.e. all mucosa could be visualized) and C and D are classified as unsuccessful.'}], 'secondaryOutcomes': [{'measure': 'Each segments ratio of subject with successful Bowel Cleansing', 'timeFrame': '1 day of scheduled colonoscopy', 'description': 'Evaluate the HCS grade evaluation, polyp or adenoma detection rate, etc.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bowel preparation'], 'conditions': ['Bowel Preparation']}, 'referencesModule': {'references': [{'pmid': '41306094', 'type': 'DERIVED', 'citation': 'Park SK, Jeon SR, Yang DH, Chun J, Cha JM. Efficacy and Safety of Bowel Cleansing with Mini S-Oral Sulfate Tablet versus the Conventional Oral Sulfate Tablet: A Prospective, Randomized, Investigator-Blinded, Multicenter, Noninferior, Phase 3 Trial. Gut Liver. 2025 Nov 27. doi: 10.5009/gnl250291. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'A prospective randomized study compared to the active control. Researchers compare colon cleansing in patients undergoing colonoscopy', 'detailedDescription': 'This is a prospective randomized study compared with active control arm. The investigators compare the colon cleansing in patients undergoing colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must provide written informed consent.\n* Male and female outpatients and inpatients aged: ≥19\n* Patients BMI shoule be ≤ 30\n\nExclusion Criteria:\n\n* Patients with past history of severe constipation (requiring repeated use of laxatives/enema or physical intervention before resolution), known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.\n* Patients with ongoing severe acute Inflammatory Bowel Disease.\n* Patients who have had previous significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection, defunctioning colostomy.\n* Pregnant women or pregnant women or pregnant women\n* Severe heart disease (cardiac failure (NYHA class 3 and 4))\n* Acute coronary artery disease within 24 weeks before screening (an unstable angina pectoris, acute myocardial infarction), clinically significant arrhythmia, hypertrophic obstruction Cardiomyopathy, valvular disease, aortic and peripheral vascular diseases.\n* People who have hypersensitivity or allergies to clinical trial drug components.'}, 'identificationModule': {'nctId': 'NCT06287606', 'briefTitle': 'A Phase 3 Clinical Trials for Bowel Preparation for Colonoscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taejoon Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Prospective, Randomized, Investigator-blinded, Parallel, Multi-center, Phase 3 Trial in Bowel Preparation for Colonoscopy', 'orgStudyIdInfo': {'id': 'CTP0302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CTP0302-A', 'description': '2 days split-dose', 'interventionNames': ['Drug: CTP0302-A']}, {'type': 'EXPERIMENTAL', 'label': 'CTP0302-B', 'description': 'One day dose', 'interventionNames': ['Drug: CTP0302-B']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional OST', 'description': '2 days split-dose', 'interventionNames': ['Drug: Conventional OST']}], 'interventions': [{'name': 'CTP0302-A', 'type': 'DRUG', 'otherNames': ['Treatment Group A'], 'description': 'Subjects randomized into group CTP0302-A will take a bowel preparation from the evening until the following morning.', 'armGroupLabels': ['CTP0302-A']}, {'name': 'CTP0302-B', 'type': 'DRUG', 'otherNames': ['Treatment Group B'], 'description': 'Subjects randomized into group CTP0302-B will take a bowel preparation on the Colonoscopy day', 'armGroupLabels': ['CTP0302-B']}, {'name': 'Conventional OST', 'type': 'DRUG', 'otherNames': ['Control group'], 'description': 'Subjects randomized into group Conventional OST will take a bowel preparation from the evening until the following morning.', 'armGroupLabels': ['Conventional OST']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Taejoon Pharmaceutical Co., Ltd.', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jaemyung Cha, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyung Hee University Hospital at Gangdong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taejoon Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}