Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-28 @ 11:21 AM
Study NCT ID:
NCT05656092
Status:
COMPLETED
Last Update Posted:
2025-02-19
First Post:
2022-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Effiacy and Safety of HIP0612 in Patients With Gastric Ulcer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013276', 'term': 'Stomach Ulcer'}], 'ancestors': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 199}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2022-12-09', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Healing rate of gastric ulcer', 'timeFrame': 'week 8', 'description': 'Including subjects endoscopically confirmed healing of gastric ulcer after 4 Weeks of treatment and complete the study'}], 'secondaryOutcomes': [{'measure': 'Healing rate of gastric ulcer', 'timeFrame': 'week 4'}, {'measure': 'Healing rate of gastric ulcer according to H.pylori infection status', 'timeFrame': 'week 4, 8'}, {'measure': 'Post-treatment resolution rate of GI symptoms', 'timeFrame': 'week 4, 8'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastric Ulcer']}, 'descriptionModule': {'briefSummary': 'A multicenter, randomized, double-blind, active-controlled, phase III study to evaluate the efficacy and safety of HIP0612 in patients with gastric ulcer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 19 years to 75 years\n* Diagnosis of active gastric ulcers according to the Sakita-Miwa classification from upper GI endoscopy\n* Patients understood the consents and purpose of this trial and signed consent form\n\nExclusion Criteria:\n\n* Patients who cannot perform endoscopy\n* Finding of malignancy, duodenal ulcer, ulcer perforation, postoperative (eg, endoscopic mucosal resection, endoscopic submucosal dissection) ulcer(s), Barrett's oesophagus measuring \\>3cm, oesophageal dysplasia, oesophageal and/or gastric varices, bleeding disorder on upper GI endoscopy\n* History of definitive acid lowering surgery or pervious oesophageal or gastric surgery (except for benign tumor excisionn, simple close of perforations)\n* Zollinger-Ellison syndrome, pyloric stenosis, oesophageal motility disorder, esophageal stricture\n* Severe hepatic disease\n* Severe renal disease, CKD\n* Bleeding disorder\n* History of malignancy or was treated for malignancy within 5 years before the start of the Visit 1\n* Patients who have taken drugs containing following list within 2 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: acid suppressive drugs, antacids, anticholinergic drugs, gastroprotective agent\n* Patients who have taken drugs containing following list within 1 weeks prior to upper GI endoscopy, or requirement of persistent use of drugs during the study period: antithrombotic agents, NSAIDs, aspirin\n* Requirement of use of excluded medications during the study\n* History of allergic reaction to the medications used in this study\n* Glucose-galactose malabsorption, Fructose intolerance, Sucrase-isomaltase deficiency\n* Use of other investigational drugs within 30 days prior to the study\n* History of alcohol or drug abuse\n* Positive to pregnancy test, nursing mother, intention on pregnancy\n* Considered by investigator as not appropriate to participate in the clinical study with other reason"}, 'identificationModule': {'nctId': 'NCT05656092', 'briefTitle': 'A Study to Evaluate the Effiacy and Safety of HIP0612 in Patients With Gastric Ulcer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hanmi Pharmaceutical Company Limited'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of HIP0612 in Patients With Gastric Ulcer', 'orgStudyIdInfo': {'id': 'HM-AESOP-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HIP0612', 'description': 'Taking HIP0612+HPP2202 once daily for 4 or 8 weeks.', 'interventionNames': ['Drug: HIP0612', 'Drug: HPP2202']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RLD2204', 'description': 'Taking RLD2204+HPP2201 once daily for 4 or 8 weeks.', 'interventionNames': ['Drug: RLD2204', 'Drug: HPP2201']}], 'interventions': [{'name': 'HIP0612', 'type': 'DRUG', 'description': 'Test drug', 'armGroupLabels': ['HIP0612']}, {'name': 'HPP2202', 'type': 'DRUG', 'description': 'Placebo drug', 'armGroupLabels': ['HIP0612']}, {'name': 'RLD2204', 'type': 'DRUG', 'description': 'Reference drug', 'armGroupLabels': ['RLD2204']}, {'name': 'HPP2201', 'type': 'DRUG', 'description': 'Placebo drug', 'armGroupLabels': ['RLD2204']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanmi Pharmaceutical Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}