Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-01-01 @ 9:01 AM
Study NCT ID:
NCT05410535
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2021-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D055656', 'term': 'Prescriptions'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D010593', 'term': 'Pharmaceutical Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'patients who participated in PEGASUS-D clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 431}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2021-12-22', 'studyFirstSubmitQcDate': '2022-06-06', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects with gallstones formed', 'timeFrame': 'at 3 years', 'description': 'The proportion of subjects with gallstones formed after gastrectomy.'}, {'measure': 'Proportion of subjects with gallstones formed', 'timeFrame': 'at 5 years', 'description': 'The proportion of subjects with gallstones formed after gastrectomy.'}, {'measure': 'The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.', 'timeFrame': 'at 3 years', 'description': 'The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.'}, {'measure': 'The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.', 'timeFrame': 'at 5 years', 'description': 'The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.'}, {'measure': 'The duration of UDCA', 'timeFrame': 'up to 5 years', 'description': 'The duration of UDCA'}, {'measure': 'The dose of UDCA', 'timeFrame': 'up to 5 years', 'description': 'The dose of UDCA'}, {'measure': 'The recurrence rate of gastric cancer', 'timeFrame': 'up to 5 years', 'description': 'The recurrence rate of gastric cancer'}, {'measure': 'The survival rate of gastric cancer', 'timeFrame': 'up to 5 years', 'description': 'The survival rate of gastric cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'Of those patients who participated in PEGASUS-D FAS clinical trial, patient must sign the informed consent form in order to participate in this extension study.\n\nThe medical records of the patients will be reviewed throughout the study.', 'detailedDescription': "Of those patients who participated in PEGASUS-D FAS clinical trial, patient must sign the informed consent form in order to participate in this extension study.\n\n* Collection of retrospective cohort data\n\n 1)The medical records from the subject's gastrectomy surgery date to Visit1 will be collected through a questionnaire and by reviewing the medical records of the patient.\n* Collection of prospective cohort data\n\n 1. Based on visit 1, if the subjects whose date of gastrectomy surgery date is more than 3 years(36 months) and less than 5 years(60 months), the subject should visit the institution at the time of 5 years(60 months, visit2) after gastrectomy surgery to evaluate data requested at visit2.\n 2. The medical records will be accessed and collected from the subject's gastrectomy surgery date up to 5 years(60 months)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAmong the PEGASUS-D Full Analysis Set (FAS) subjects, those who agree to participate in this clinical trial or those who can collect retrospective cohort data after waiving consent according to the consent waiver criteria\n\nExclusion Criteria:\n\nA person who, at the discretion of the investigator, is deemed difficult to participate in this clinical trial.'}, 'identificationModule': {'nctId': 'NCT05410535', 'briefTitle': 'To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Daewoong Pharmaceutical Co. LTD.'}, 'officialTitle': 'A Multi-center, Phase IV, Extension Study in PEGASUS-D Trial to Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gastrectomy in Patients With Gastric Cancer', 'orgStudyIdInfo': {'id': 'DW_UDCA005_P401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients who received UDCA 600mg', 'description': 'Patients who participated in PEGASUS-D clinical trial and received UDCA 600mg', 'interventionNames': ['Drug: Patients who continued UDCA 300mg medication', 'Other: Patients who discontinued UDCA 300mg prescription']}, {'type': 'EXPERIMENTAL', 'label': 'Patients who received UDCA 300mg', 'description': 'Patients who participated in PEGASUS-D clinical trial and received UDCA 300mg', 'interventionNames': ['Drug: Patients who continued UDCA 300mg medication', 'Other: Patients who discontinued UDCA 300mg prescription']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Patients who received Placebo', 'description': 'Patients who participated in PEGASUS-D clinical trial and received Placebo', 'interventionNames': ['Drug: Patients who continued UDCA 300mg medication', 'Other: Patients who discontinued UDCA 300mg prescription']}], 'interventions': [{'name': 'Patients who continued UDCA 300mg medication', 'type': 'DRUG', 'description': 'patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial', 'armGroupLabels': ['Patients who received Placebo', 'Patients who received UDCA 300mg', 'Patients who received UDCA 600mg']}, {'name': 'Patients who discontinued UDCA 300mg prescription', 'type': 'OTHER', 'description': 'patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial', 'armGroupLabels': ['Patients who received Placebo', 'Patients who received UDCA 300mg', 'Patients who received UDCA 600mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'DoJoong Park', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'DoJoong Park', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daewoong Pharmaceutical Co. LTD.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}