Ignite Creation Date:
2025-12-24 @ 12:06 PM
Ignite Modification Date:
2026-01-29 @ 12:50 PM
Study NCT ID:
NCT01645761
Status:
COMPLETED
Last Update Posted:
2014-01-22
First Post:
2012-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010437', 'term': 'Peptic Ulcer'}], 'ancestors': [{'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-20', 'studyFirstSubmitDate': '2012-07-16', 'studyFirstSubmitQcDate': '2012-07-18', 'lastUpdatePostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication rate', 'timeFrame': '4 weeks', 'description': 'Intention-to-treat analysis and per-protocol analysis to compare the eradication rate of the 7-day standard PPI-based triple therapy plus endonase with that of the 7-day standard PPI-based triple therapy'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '4 weeks', 'description': 'Difference in the number of participants with adverse events between patients receiving standard triple therapy plus endonase and patients receiving control treatment'}, {'measure': 'Number of participants taking over 85% of medicine', 'timeFrame': '4 weeks', 'description': 'Difference in the number of participants taking over 85% of medicine between patients receiving standard triple therapy plus endonase and patients receiving control treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Helicobacter pylori eradication', 'Peptic ulcer'], 'conditions': ['Gastric Ulcer Associated With Helicobacter Pylori']}, 'referencesModule': {'references': [{'pmid': '25167799', 'type': 'DERIVED', 'citation': 'Bang CS, Kim YS, Park SH, Kim JB, Baik GH, Suk KT, Yoon JH, Kim DJ. Additive Effect of Pronase on the Eradication Rate of First-Line Therapy for Helicobacter pylori Infection. Gut Liver. 2015 May 23;9(3):340-5. doi: 10.5009/gnl13399.'}]}, 'descriptionModule': {'briefSummary': 'Endonase, a kind of protease, is known to cause both extensive degradation of mucins and a reduction in mucus viscosity. As part of the search for more effective forms of therapy against H. pylori when it colonizes not only the surface of the surface mucosal cells but also the surface mucous gel layer covering the mucosal surface of the stomach. The investigators decided to investigate whether or not endonase might have additive effect of pronase on the efficacy of eradication therapy against Helicobacter pylori.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale or Female with 18 years or more of age without history of H. pylori eradication AND\n\n1. Patients with H. pylori associated peptic ulcer in scar stage, OR\n2. Non-ulcer dyspepsia patients with H. pylori infection\n\nExclusion Criteria:\n\n1. Under 18 years, OR\n2. Patients with a history of previous treatment of H. pylori infection, OR\n3. Pregnant or Breast feeding women, OR\n4. Patients with severe renal, liver, or heart disease, OR\n5. Patients with gastric malignancy, OR\n6. Patients with a history of drug allergy or hypersensitivity, OR\n7. Patients who had received treatment with antibiotics or proton pump inhibitors, H2 Blocker, Bismuth preparation, Anticoagulant, Ketoconazole, Glucocorticoid during the 2 weeks preceding endoscopy'}, 'identificationModule': {'nctId': 'NCT01645761', 'briefTitle': 'Additive Effect of Endonase on Eradication Rate of First Line Therapy for Helicobacter Pylori', 'organization': {'class': 'OTHER', 'fullName': 'Chuncheon Sacred Heart Hospital'}, 'officialTitle': 'Additive Effect of Endonase on Eradication Rate of the 7-day Standard Proton Pump Inhibitor-based Triple Therapy for Helicobacter Pylori', 'orgStudyIdInfo': {'id': 'CSHH Endonase 1'}, 'secondaryIdInfos': [{'id': 'CLDD 1', 'type': 'OTHER', 'domain': 'CSHH CLDD 1'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PPI-based triple therapy with endonase', 'description': '7-day standard proton pump inhibitor-based triple therapy (the standard dosage of PPI, 1,000 mg of amoxicillin and 500 mg of clindamycin twice daily for one week) plus 20,000 units of endonase twice daily for one week.', 'interventionNames': ['Drug: Endonase']}, {'type': 'NO_INTERVENTION', 'label': 'PPI-based triple therapy', 'description': '7-day standard proton pump inhibitor-based triple therapy (the standard dosage of PPI, 1,000 mg of amoxicillin and 500 mg of clindamycin twice daily for one week)'}], 'interventions': [{'name': 'Endonase', 'type': 'DRUG', 'description': 'PPI- based triple therapy with endonase', 'armGroupLabels': ['PPI-based triple therapy with endonase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200-100', 'city': 'Chuncheon', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Chuncheon Sacred Heart Hospital', 'geoPoint': {'lat': 37.87472, 'lon': 127.73417}}], 'overallOfficials': [{'name': 'Jin Bong Kim, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Internal Medicine, Hallym university college of medicine'}, {'name': 'Yeon Soo Kim, MD, PhD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Internal Medicine, Hallym University College of Medicine'}, {'name': 'Chang Seok Bang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal Medicine, Hallym University of College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chuncheon Sacred Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Yeonsoo Kim', 'investigatorAffiliation': 'Chuncheon Sacred Heart Hospital'}}}}