Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT00272467
Status:
COMPLETED
Last Update Posted:
2015-04-29
First Post:
2006-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C052785', 'term': 'rebamipide'}, {'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-27', 'studyFirstSubmitDate': '2006-01-04', 'studyFirstSubmitQcDate': '2006-01-04', 'lastUpdatePostDateStruct': {'date': '2015-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gastric ulcer healing rate', 'timeFrame': 'at 12 weeks after the initial administration of the study medication', 'description': 'Rebamipide showed 81.5\\~87.8% of gastric ulcer healing rate which was not inferior to 82.5\\~87.8% healing rate of Omeprazole.'}], 'secondaryOutcomes': [{'measure': 'Gastric ulcer healing rate in cases with successful H.pylori eradication and H.pylori eradication failure (12 weeks after administration of the study medication.)', 'timeFrame': 'at 12 weeks after the initial administration of the study medication'}, {'measure': 'Serum gastrin level', 'timeFrame': 'at 8 and 12 weeks after the initial administration of study medication'}, {'measure': 'Economical efficiency', 'timeFrame': 'drug cost/effect ratio', 'description': 'Rebamipide was more cost effective than Omeparzole for 7 weeks of gastric ulcer treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Helicobacter pylori', 'Stomach ulcer', 'Rebamipide', 'Omeprazole'], 'conditions': ['Stomach Ulcer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the ulcer healing efficacy of rebamipide in comparison with omeprazole in Helicobacter pylori-positive gastric ulcer after eradication therapy.', 'detailedDescription': 'This study is designed to evaluate the ulcer healing efficacy of rebamipide administered following the eradication therapy in comparison with the well known PPI, omeprazole. This is a double-blind, comparative study which is expected to prove the role of rebamipide in gastric ulcer healing after the eradication therapy. This study may contribute to further clinical research on a new type of ulcer treatment by looking at the treatment modality based on the enhancement of defensive factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 20 or older at the time of writing the informed consent\n* H. pylori-positive patient.\n* Patients who are diagnosed with gastric ulcer by endoscopy and have the following ulcer characteristics; Non-scarring ulcer (stage A1, A2, H1, H2 according to the Sakita-Miwa classification), Single ulcer, Ulcer size of 5 to 20mm in diameter\n\nExclusion Criteria:\n\n* Patients who previously underwent H. pylori eradication therapy\n* Malignant gastric ulcer\n* Linear ulcer\n* Patients with history of upper GI tract resection or vagotomy\n* Patients with continuous NSAIDs use within 4 weeks prior to study initiation\n* Patients with ulcer complications including perforation or pyloric stenosis\n* Gastric ulcer prone to bleeding (e.g. exposed blood vessels at ulcer base)\n* Patients with infectious mononucleosis\n* Patients with known hypersensitivity to penicillin, clarithromycin, omeprazole, amoxicillin or rebamipide\n* Patients on medications such as terfenadine or pimozide which are contraindicated with clarithromycin usage\n* Pregnant or possibly pregnant women, lactating women, or those with a plan to conceive during this study\n* Blood test results of Hb ≤ 8.0 g/dl, platelet ≤50,000 /㎕, total WBC ≤ 4000/㎕ or ≥ 10,000/㎕, and with serum test results showing the levels of AST, ALT, ALP, LDH, BUN, and creatinine exceeding twice the normal range of respective institution.\n* Other patients deemed not eligible for this study by investigators'}, 'identificationModule': {'nctId': 'NCT00272467', 'briefTitle': 'Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Korea Otsuka International Asia Arab'}, 'officialTitle': 'A Comparative Study on the Healing Effects of Rebamipide and Omeprazole in Helicobacter Pylori-positive Gastric Ulcer After Eradication Therapy', 'orgStudyIdInfo': {'id': 'OIAAMCTIVK205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rebamipide', 'description': '1. Dosage (1) The eradication therapy period (for all cases) Amoxicillin 2,000mg/day, clarithromycin 1,000 mg/day and omeprazole 40 mg/day. b.i.d. (morning and evening), oral administration. (2) The ulcer treatment period (on a double-blind basis) Rebamipide 100mg, t.i.d. (before breakfast, evening, before bed).\n2. Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks', 'interventionNames': ['Drug: Rebamipide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omeprazole', 'description': '1. Dosage (1) The eradication therapy period (for all cases) Amoxicillin 2,000mg/day, clarithromycin 1,000 mg/day and omeprazole 40 mg/day. b.i.d. (morning and evening), oral administration. (2) The ulcer treatment period (on a double-blind basis) omeprazole 20mg, once daily (before breakfast)\n2. Drug period (1) The eradication therapy period: 1 week (2) The ulcer treatment period: 7 weeks', 'interventionNames': ['Drug: Omeprazole']}], 'interventions': [{'name': 'Rebamipide', 'type': 'DRUG', 'otherNames': ['Mucosta'], 'description': '1. Brand name: Mucosta® Tab.\n2. Generic name: Rebamipide.\n3. Chemical name:\n\n (±)-2-(4-chlorobenzoylamino)-3-\\[2(1H)-quinolinon-4-yl\\]propionic acid.\n4. Formulation: Tablet (White, film-coated tablet).\n5. Strength: One tablet contains rebamipide 100mg.\n6. Storage condition: 15℃\\~25℃.\n7. Manufacturer: Korea Otsuka Pharmaceuticals', 'armGroupLabels': ['Rebamipide']}, {'name': 'Omeprazole', 'type': 'DRUG', 'otherNames': ['Losec'], 'description': '1. Brand name: Losec® Cap.\n2. Generic name: Omeprazole.\n3. Chemical name:\n\n5-melthoxy-2-{{{4-melthoxy-3.5-dlmethyl2-pyridinyl}methyl}sulp- hinyl}-1H-benzimidazole sodium. 4) Formulation: Capsule. 5) Strength: One capsule contains omeprazole 20mg. 6) Storage condition: 15℃\\~25℃. 7) Manufacturer: AstraZenaca Korea.', 'armGroupLabels': ['Omeprazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The 1st Affiliated hospital - Zhongshan Univ.', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nanfang Hospital - Nanfang Medical Univ.', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '710032', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Xijing Hospital - The 4th Military Medical Univ', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The 1st Affiliated Hospital - Medical School of Zhejiang Univ.', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '200001', 'city': 'Shanghai', 'country': 'China', 'facility': 'Ren-Ji Hospital - Shanghai Second Medical Univ.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '425-707', 'city': 'Ansan', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 36.8741, 'lon': 126.2116}}, {'zip': '120-752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital, Seoul National University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Jin-Ho Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center, Ulsan University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea Otsuka International Asia Arab', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Zhejiang Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'Korea Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}