Ignite Creation Date:
2025-12-24 @ 10:03 PM
Ignite Modification Date:
2025-12-30 @ 1:59 PM
Study NCT ID:
NCT05249335
Status:
UNKNOWN
Last Update Posted:
2022-02-21
First Post:
2022-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicenter, prospective, investigator single-blinded, randomized study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 256}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2022-01-03', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient satisfaction assessed by questionnaire', 'timeFrame': 'Two days (from day of first dosing to day of colonoscopy)', 'description': 'maximum score 10, minimum score0 , higher scores mean a better satisfaction'}, {'measure': 'Adenoma/Polyp detection rate, ADR /PDR', 'timeFrame': 'Two days (from day of first dosing to day of colonoscopy)', 'description': 'Adenoma/Polyp detection rate over 25%'}, {'measure': 'clean cecal intubation time, colonoscopy time', 'timeFrame': 'Two days (from day of first dosing to day of colonoscopy)', 'description': 'clean cecal intubation time, colonoscopy time'}], 'primaryOutcomes': [{'measure': 'Successful cleaning rate1', 'timeFrame': 'Two days (from day of first dosing to day of colonoscopy)', 'description': '%Patient with Boston Bowel Preparation Scale (BBPS) scored over 2 in all segment'}, {'measure': 'Successful cleaning rate2', 'timeFrame': 'Two days (from day of first dosing to day of colonoscopy)', 'description': '%Patient with HCS-graded A or B'}], 'secondaryOutcomes': [{'measure': 'Treatment compliance', 'timeFrame': 'Two days (from day of first dosing to day of colonoscopy)', 'description': '%Patient who have completed taking the investigational products'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'orafang', 'bowel cleaning'], 'conditions': ['Colonic Disease', 'Intestinal Disease']}, 'referencesModule': {'references': [{'pmid': '38492010', 'type': 'DERIVED', 'citation': 'Kang HS, Na SY, Yoon JY, Jung Y, Seo GS, Cha JM. Efficacy, tolerability, and safety of oral sulfate tablet versus 2 L-polyethylene glycol/ascorbate for bowel preparation in older patients: prospective, multicenter, investigator single-blinded, randomized study. J Gastroenterol. 2024 May;59(5):402-410. doi: 10.1007/s00535-024-02089-9. Epub 2024 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'This study compares the effectiveness and stability of intestinal tablet (OST), an oral sulfate table (OST), developed in the form of pills, with 2L-PEG/Asc for examinees aged 70 or older who are scheduled for colonoscopy.', 'detailedDescription': 'This study is comparison for efficacy and safety of bowel preparation between oral sulfate table and 2L-polyethylene glycol/ascorbate in elderly: multicenter, prospective, investigator single-blinded, randomized study. A total of 256 subjects will participate to this study and be assigned to the test group or the control group. The subject will administer the first dose of assigned investigational product in the evening prior to the scheduled colonoscopy. Subject will take the second dose early in the morning of the colonoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age over 70\n* Patients who is scheduled a colonoscopy\n* Patients who is informed and give a consent in voluntary\n\nExclusion Criteria:\n\n* History of colectomy\n* Patients over American Society of Anesthesiology class III\n* Patients who has difficulty swallowing\n* In the case of abnormal findings requiring treatment in the basic blood test\n* Patients with uncontrollable chronic diseases\n* Patients suspected of having Paralytic ileus or intestinal obstruction.\n* Patients who complains of alarm sign (severe abdominal pain, weight loss, anemia, gastrointestinal bleeding, etc.)\n* Patients who has a history of drug abuse and addiction\n* Patients who for any reason, are deemed by the Investigator to be inappropriate for this study'}, 'identificationModule': {'nctId': 'NCT05249335', 'briefTitle': 'Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmbio Korea Co., Ltd.'}, 'officialTitle': 'Comparison for Efficacy and Safety of Bowel Preparation Between Oral Sulfate Table and 2L-polyethylene Glycol/Ascorbate in Elderly: Multicenter, Prospective, Investigator Single-blinded, Randomized Study', 'orgStudyIdInfo': {'id': 'unconfirmed yet'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OST', 'description': '2 days split dosing regimen', 'interventionNames': ['Drug: OST']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2L-PEG/Asc', 'description': '2 days split dosing regimen', 'interventionNames': ['Drug: 2L-PEG/Asc']}], 'interventions': [{'name': 'OST', 'type': 'DRUG', 'description': 'The subject will receive Orafang for colonoscopy', 'armGroupLabels': ['OST']}, {'name': '2L-PEG/Asc', 'type': 'DRUG', 'description': 'The subject will receive 2L-PEG/Asc for colonoscopy', 'armGroupLabels': ['2L-PEG/Asc']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Cha Jaemyeong, M.D, Ph.D', 'role': 'CONTACT', 'email': 'clicknox@hanmail.net', 'phone': '+82-2-440-6113'}, {'name': 'Yoon Jinyeong', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Cha Jaemyeong, M.D, Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Kyung Hee University Hospital at Gangdong'}, {'name': 'Gang Hoseok, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HALLYM UNIV. MEDICAL CENTER'}, {'name': 'Seo Geomseok, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wonkwang University Hospital'}, {'name': 'Jeong Yunho, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soon Chun Hanyang University College of Medicine'}, {'name': 'Na Suyeong, M.D, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Incheon St.Mary's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmbio Korea Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}