Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-01-06 @ 10:46 AM
Study NCT ID:
NCT03469167
Status:
COMPLETED
Last Update Posted:
2018-03-19
First Post:
2018-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010438', 'term': 'Peptic Ulcer Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-16', 'studyFirstSubmitDate': '2018-03-05', 'studyFirstSubmitQcDate': '2018-03-16', 'lastUpdatePostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Initial hemostasis rate', 'timeFrame': 'Within 10 minutes after first endoscopy session', 'description': 'Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.'}], 'secondaryOutcomes': [{'measure': 'Recurrent bleeding rate', 'timeFrame': 'Within 72 hours', 'description': 'If any of the following conditions are met, an endoscopy will verify for rebleeding.\n\n* Associated with overt signs of GI bleed (melena, and/or hematemesis)\n* Instability of Vital signs (\\<80/60 mmHg of blood pressure, and/or \\>120 beats/min of pulse)\n* Decrease in hemoglobin of at least 2 g/dl after Initial hemostasis\n* bleeding can be confirmed directly (direct visualization)'}, {'measure': 'Time required for treatment', 'timeFrame': '0 day', 'description': 'The time from when the endoscope is inserted to when the endoscope treatment is completed.'}, {'measure': 'Wound healing effect of peptic ulcer', 'timeFrame': 'After 3 days (72 hours)', 'description': 'Evaluation of Stage Classification of Gastric Ulcer by Sakita-Miwa.'}, {'measure': 'Usability for the delivery system', 'timeFrame': '0 day', 'description': 'Evaluation of success for the delivery system'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bleeding'], 'conditions': ['Peptic Ulcer Bleeding']}, 'descriptionModule': {'briefSummary': 'This is a prospective, single-blinded, randomized study to evaluate the efficacy and safety of CEGP003 in patients with acute peptic ulcers bleeding, compared to endoscopic epinephrine injection therapy.', 'detailedDescription': 'CEGP003 is wound dressing solution containing Hydroxyethyl-cellulose and EGF. Epidermal growth factor (EGF) stimulates cell growth and differentiation by binding to its receptor, which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a peptic ulcers bleeding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)\n\nExclusion Criteria:\n\n* Subjects who have a history of malignant tumor in upper gastro-intestinal site\n* Subjects with platelet and coagulation dysfunction (PLT \\< 50E9/L, INR \\> 2)\n* Subjects that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 72 hours after the treatment\n* Subjects with one or more bleeding sources\n* Subjects who are pregnant or breast-feeding\n* Subject who are allergic or have a hypersensitive reaction to Hydroxyethyl-cellulose or EGF\n* Subjects who have undergone endoscopically therapies within the last 7 days\n* Subjects who are considered not suitable for the study by significant disease\n* Subjects who are not able to comply with the study requirements\n* Subjects who are currently enrolled in another clinical study which can impact the study within 30 days of screening\n* Subjects who are considered not suitable for the study by the investigator'}, 'identificationModule': {'nctId': 'NCT03469167', 'acronym': 'CEGP003', 'briefTitle': 'Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding', 'organization': {'class': 'INDUSTRY', 'fullName': 'CGBio Inc.'}, 'officialTitle': 'Clinical Study to Evaluate Efficacy and Safety of "CEGP003(Wound Dressing Solution Containing EGF)" for Achieving Hemostasis and Protecting Ulcer in Patients With Acute Peptic Ulcer Bleeding: A Prospective, Randomized Trial', 'orgStudyIdInfo': {'id': 'CGB-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CEGP003', 'interventionNames': ['Device: CEGP003']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Injection Tx', 'interventionNames': ['Device: Injection Tx']}], 'interventions': [{'name': 'CEGP003', 'type': 'DEVICE', 'otherNames': ['EGF'], 'description': 'Application of CEGP003 to peptic ulcer bleeding', 'armGroupLabels': ['CEGP003']}, {'name': 'Injection Tx', 'type': 'DEVICE', 'otherNames': ['epinephrine injection'], 'description': 'Injection of epinephrine to peptic ulcer bleeding', 'armGroupLabels': ['Injection Tx']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Don Haeng Lee, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inha University Hospital'}, {'name': 'Su Jin Hong, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soon Chun Hyang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CGBio Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}