Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2026-01-01 @ 3:46 PM
Study NCT ID:
NCT02648659
Status:
COMPLETED
Last Update Posted:
2018-08-09
First Post:
2016-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-08-26', 'releaseDate': '2020-08-12'}, {'resetDate': '2020-09-17', 'releaseDate': '2020-08-29'}], 'estimatedResultsFirstSubmitDate': '2020-08-12'}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C119615', 'term': 'ilaprazole'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D017291', 'term': 'Clarithromycin'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-07', 'studyFirstSubmitDate': '2016-01-05', 'studyFirstSubmitQcDate': '2016-01-06', 'lastUpdatePostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eradication rate after tailored therapy assessed by urea breath test', 'timeFrame': 'Test at 4 -6 weeks after completion of medication', 'description': 'After completion of 14days tailored therapy, the participants will be followed at 4-6 weeks with urea breath test (UBT). The eradication rate will be assessed by the result of UBT.'}], 'secondaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by questionnaire', 'timeFrame': 'Questionnaire and diary during medication for 14days', 'description': 'During the medication of tailored therapy, the participants will be asked to check the compliance and adverse events with diary and questionnaire.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Peptic Ulcer']}, 'descriptionModule': {'briefSummary': 'This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.', 'detailedDescription': 'This study assessed the effect of tailored eradication therapy according to Clarithromycin resistance in Helicobacter pylori patients.\n\nThe patients with gastric or duodenal ulcer by endoscopy were registered at the study and inspected Rapid Urease test, Biopsy, IgG-Hp antibody.\n\nThe tailored eradication therapy was prescribed to patients that confirmed Helicobacter pylori positive in two or more of among the three tests for 14 days. Through this, This study is to assess the effectiveness of eradication rate and to evaluate safety and tolerability of Ilaprazole 10mg qid treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • 20 year old ≤ Male or female \\< 80 year old\n\n * Among Patients with gastric or duodenal ulcer by endoscopy, Subject who is identified Helicobacter pylori-positive in the conduct of two or more of the following tests ; Rapid Urease test, Biopsy test, IgG-Hp antibody test.\n * Subject who fully understands conditions of clinical trial\n * Subject who agrees to participate and spontaneously sign the ICF\n\nExclusion Criteria:\n\n* Known hypersensitivity to experimental and concomitant drugs\n* Subjects who are taking contraindicated medications for experimental and concomitant drug.\n* Subjects with abnormal levels in the laboratory tests\n\n * Total Bilirubin, Creatinine\\> 1.5 times upper limit of normal\n * AST, ALT, Alkaline phosphatase, BUN\\> 2 times upper limit of normal\n* Administrated of PPI, antibiotic medication within 2 weeks prior to commencement of the study.\n* Pregnant and/or lactating women\n* Reproductive aged women not using contraception\n* Uncontrolled diabetics\n* Uncontrolled hypertension\n* Uncontrolled liver dysfunction\n* Alcoholics\n* Subjects with a history or possibility of digestive malignancy within 5 years\n* Subjects with a history of gastrectomy or esophagectomy\n* Subjects with hereditary diseases such as Galactose intolerance, Lapp lactose deficiency, glucose-galactose malabsorption\n* Subjects participating in a clinical trial before another trial within 30 days\n* Inconsistence judged subject by researcher'}, 'identificationModule': {'nctId': 'NCT02648659', 'briefTitle': 'The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in H.Pylori Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kyungpook National University Hospital'}, 'officialTitle': 'The Pilot Study on Tailored Eradication Therapy According to Clarithromycin Resistance in Helicobacter Pylori Patients', 'orgStudyIdInfo': {'id': 'KNUMC-JSW-ILA01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'triple with clarithromycin', 'description': 'Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin bid for 2 weeks', 'interventionNames': ['Drug: Ilaprazole', 'Drug: Amoxicillin', 'Drug: Clarithromycin']}, {'type': 'EXPERIMENTAL', 'label': 'triple with metronidazole', 'description': 'Ilaprazole 10mg qid, Amoxicillin 500mg qid, Metronidazole 500mg tid for 2 weeks', 'interventionNames': ['Drug: Ilaprazole', 'Drug: Amoxicillin', 'Drug: Metronidazole']}, {'type': 'EXPERIMENTAL', 'label': 'quadruple', 'description': 'Ilaprazole 10mg qid, Amoxicillin 500mg qid, Clarithromycin 500mg bid, Metronidazole 500mg tid for 2 weeks', 'interventionNames': ['Drug: Ilaprazole', 'Drug: Amoxicillin', 'Drug: Clarithromycin', 'Drug: Metronidazole']}], 'interventions': [{'name': 'Ilaprazole', 'type': 'DRUG', 'otherNames': ['Noltec®'], 'description': 'Ilaprazole 10mg 1tablet qid(4 times/day)', 'armGroupLabels': ['quadruple', 'triple with clarithromycin', 'triple with metronidazole']}, {'name': 'Amoxicillin', 'type': 'DRUG', 'otherNames': ['Pamoxin®'], 'description': 'Amoxicillin 500mg 1capsule qid(4times/day)', 'armGroupLabels': ['quadruple', 'triple with clarithromycin', 'triple with metronidazole']}, {'name': 'Clarithromycin', 'type': 'DRUG', 'otherNames': ['Clafaxin®'], 'description': 'Clarithromycin 500mg 1tablet bid(2times/day)', 'armGroupLabels': ['quadruple', 'triple with clarithromycin']}, {'name': 'Metronidazole', 'type': 'DRUG', 'otherNames': ['Flasinyl®'], 'description': 'Metronidazole 250mg 2tablets tid(3times/day)', 'armGroupLabels': ['quadruple', 'triple with metronidazole']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Seong Woo Jeon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook national university medical center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associated Professor', 'investigatorFullName': 'Seong Woo Jeon', 'investigatorAffiliation': 'Kyungpook National University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-08-12', 'type': 'RELEASE'}, {'date': '2020-08-26', 'type': 'RESET'}, {'date': '2020-08-29', 'type': 'RELEASE'}, {'date': '2020-09-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Seong Woo Jeon, Associated Professor, Kyungpook National University Hospital'}}}}