Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT05923918
Status:
UNKNOWN
Last Update Posted:
2023-06-28
First Post:
2023-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Safety and Efficacy of PBK_M2101
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013431', 'term': 'Sulfates'}], 'ancestors': [{'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D013464', 'term': 'Sulfuric Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 246}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-20', 'studyFirstSubmitDate': '2023-05-18', 'studyFirstSubmitQcDate': '2023-06-20', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful cleansing rate', 'timeFrame': 'From day of first dosing to day of colonoscopy', 'description': '%Patient with HCS-graded A or B'}], 'secondaryOutcomes': [{'measure': 'Overall cleansing rate', 'timeFrame': 'From day of first dosing to day of colonoscopy', 'description': '%Patient with each HCS-grade (A, B, C, D)'}, {'measure': 'Mean segmental cleansing score', 'timeFrame': 'From day of first dosing to day of colonoscopy', 'description': '5 Segment: Rectum, Sigmoid colon, Descending colon, Transverse colon, Ascending colon/cecum.'}, {'measure': 'Mean cecal intubation time', 'timeFrame': 'From day of first dosing to day of colonoscopy'}, {'measure': 'Mean colonoscopy withdrawal time', 'timeFrame': 'From day of first dosing to day of colonoscopy'}, {'measure': 'Treatment compliance', 'timeFrame': 'From day of first dosing to day of colonoscopy', 'description': 'Dosage taken/Dosage scheduled'}, {'measure': 'Patient satisfaction', 'timeFrame': 'From day of first dosing to day of colonoscopy', 'description': 'Subject questionnaire (Taste, Difficulty, Ease of taking)'}, {'measure': 'Polyp detection rate', 'timeFrame': 'From day of first dosing to day of colonoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intestinal Disease', 'Colonic Diseases', 'Gastrointestinal Disease', 'Digestive System Disease']}, 'descriptionModule': {'briefSummary': 'This clinical trial was prospective, randomized, single-blind, 3-treatment arm, parallel treatment group, and active-controlled. , Multi-center, Phase 3 confirmatory clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who is informed and give a consent in voluntary\n* Patients who is scheduled a esophagogastroduodenoscopy and colonoscopy\n* BMI 19≤and\\<30\n\nExclusion Criteria:\n\n* Patients who participate in other interventional study or had participated within 30 days before screening\n* Pregnant or breast-feeding women who do not want to stop breast-feeding\n* Uncontrolled hypertension\n* Uncontrolled diabetes\n* Fluid or electrolyte (Na, K, Ca, Mg, chloride, bicarbonate) disturbance\n* HIV infection and/or chronic hepatitis B or C\n* Patients who has a difficulty to participate because of severe nausea or vomiting\n* History of colon surgery and abdominal surgery within 6 month; need an emergency surgery'}, 'identificationModule': {'nctId': 'NCT05923918', 'briefTitle': 'A Study to Evaluate Safety and Efficacy of PBK_M2101', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmbio Korea Co., Ltd.'}, 'officialTitle': 'A Prospective, Randomized, Parallel, Multi-center, Phase 3 Trial to Evaluate Safety and Efficacy of PBK_M2101', 'orgStudyIdInfo': {'id': 'PBK_M2101_301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'test 1', 'description': 'PBK\\_M2101, 2-Day Regimen', 'interventionNames': ['Drug: PBK_M2101 2-Day']}, {'type': 'EXPERIMENTAL', 'label': 'test 2', 'description': 'PBK\\_M2101, 1-Day Regimen', 'interventionNames': ['Drug: PBK_M2101 1-Day']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'active Comparator', 'description': 'active Comparator, 2-Day Regimen', 'interventionNames': ['Drug: Oral Sulfate Tablet 2-Day']}], 'interventions': [{'name': 'PBK_M2101 2-Day', 'type': 'DRUG', 'description': 'Subjects who are randomized into group test 1 will receive bowel preparation from evening to next morning.', 'armGroupLabels': ['test 1']}, {'name': 'PBK_M2101 1-Day', 'type': 'DRUG', 'description': 'Subjects who are randomized into group test 2 will receive bowel preparation on the same-day.', 'armGroupLabels': ['test 2']}, {'name': 'Oral Sulfate Tablet 2-Day', 'type': 'DRUG', 'description': 'Subjects who are randomized into group active comparative will receive bowel preparation from evening to next morning.', 'armGroupLabels': ['active Comparator']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Byeon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Manager Clinical Trial team, Pharmbio Korea', 'role': 'CONTACT', 'email': 'cr@pharmbio.co.kr', 'phone': '+82-2-587-2551'}], 'overallOfficials': [{'name': 'Byeon, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmbio Korea Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}