Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-29 @ 7:06 PM
Study NCT ID:
NCT06317350
Status:
COMPLETED
Last Update Posted:
2025-02-19
First Post:
2024-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Efficacy and Safety of GNS-212-E in Bowel Preparation for Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 318}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2024-03-12', 'studyFirstSubmitQcDate': '2024-03-12', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the successful % of bowel preparation before colonoscopy (colon cleanliness) using the HCS (Harefield Cleansing Scale)', 'timeFrame': 'on the day of scheduled colonoscopy', 'description': 'HCS grading of A and B would be classified as successful while C and D would be classified as not successful'}], 'secondaryOutcomes': [{'measure': 'Overall rate of bowel preparation', 'timeFrame': 'On the day of colonoscopy', 'description': 'Percentage of test subjects for respective HCS grades'}, {'measure': 'Overall patient satisfaction and compliance', 'timeFrame': 'before and on the day of colonoscopy', 'description': 'Subject questionnaire evaluation total volume, taste etc.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colonoscopy', 'Bowel preparation'], 'conditions': ['Colonoscopy', 'Bowel Preparation']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, single-blind, parallel, active-controlled, and multi-center Phase III clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult men and women between 19 years and 79 age or older as of the date of consent in writing\n2. 19 kg/㎡ ≤ BMI \\< 30 kg/㎡\n3. a prospective colonoscopy patient\n4. For women of childbearing potential, those who agree to use a medically acceptable contraceptive method\\* during the clinical trial period\n\n \\*hormonal contraceptive, implantation of intrauterine device or intrauterine system, Infertility procedures/surgery (e.g., bilateral ovarian ligation, vasectomy)\n5. A person who voluntarily agrees to participate in this clinical trial and signs a written agreement Abbreviation\n6. Women of childbearing potential must have a negative serum or urine pregnancy test before Investigational Product administration\n\nExclusion Criteria:\n\n1. A person having constipation who is regularly administered laxatives or gastrointestinal motility promoters\n2. A person with a history of significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection\n3. A person diagnosed with acute coronary disease, arrhythmia, cardiomyopathy, cardiac valvular disease, aortic and peripheral vascular disease\n4. Active infection or high fever above 38°C\n5. Uncontrolled chronic medical illnesses or suspected symptoms that hinder participation such as major cardiac, renal, and metabolic (ex, Subjects with severe renal disease).\n6. Clinically significant abnormal laboratory values of screening.(Creatinine, AST or ALT )\n7. Active hepatitis B or hepatitis C with positive HBsAg and HCV Ab tests at screening\n8. Positive for Human Immuno-deficiency Virus (HIV) at the time of screening\n9. Severe nausea or vomiting\n10. Severe abdominal distension or abdominal pain\n11. A person prone to aspiration or reflux\n12. A person who undergoes colonoscopy for the following therapeutic purpose (1) balloon dilatation of the stenosis area (2) non-toxic giant colon or decompression of the S-phase colitis (sigmoid volvulus) (3) Removal of foreign substances (4) Vascular dysplasia, ulcer, tumor and treatment of bleeding after polypectomy\n13. A person who is hypersensitive to the ingredients of a clinical trial drug\n14. Pregnant woman or a lactating woman\n15. A person who has serious mental disabilities\n16. A person who requires the administration of drugs prohibited from concomitant use\n17. A person who is administered another investigational drug or has been provided with a clinical trial medical device within 6 months prior to participating in a clinical trial\n18. The person whom the investigator determines to be unsuitable for this study'}, 'identificationModule': {'nctId': 'NCT06317350', 'acronym': 'GNS-212-E', 'briefTitle': 'Clinical Study to Evaluate the Efficacy and Safety of GNS-212-E in Bowel Preparation for Colonoscopy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gunkang Pharmaceuticals, Inc'}, 'officialTitle': 'A Prospective, Randomized, Parallel, Multi-center, Active Controlled, Single Blind (Assessor), Phase 3 Clinical Trial in Bowel Preparation for Colonoscopy', 'orgStudyIdInfo': {'id': 'GNS-212-E'}, 'secondaryIdInfos': [{'id': '101772', 'type': 'OTHER', 'domain': 'MFDS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GNS-212-E1', 'interventionNames': ['Drug: GNS-212-E1']}, {'type': 'EXPERIMENTAL', 'label': 'GNS-212-E2', 'interventionNames': ['Drug: GNS-212-E2']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GNS-212-ER', 'interventionNames': ['Drug: GNS-212-ER']}], 'interventions': [{'name': 'GNS-212-E1', 'type': 'DRUG', 'description': 'Subjects who are randomized into this group will take GNS-212-E1 from the evening before colonoscopy to the morning of colonoscopy.', 'armGroupLabels': ['GNS-212-E1']}, {'name': 'GNS-212-E2', 'type': 'DRUG', 'description': 'Subjects who are randomized into this group will take GNS-212-E2 from the evening before colonoscopy to the morning of colonoscopy.', 'armGroupLabels': ['GNS-212-E2']}, {'name': 'GNS-212-ER', 'type': 'DRUG', 'description': 'Subjects who are randomized into this group will take active control drug (PEG3350) from the evening before colonoscopy to the morning of colonoscopy.', 'armGroupLabels': ['GNS-212-ER']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Byeong Gwan Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gunkang Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}