Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-28 @ 1:27 AM
Study NCT ID:
NCT01190657
Status:
COMPLETED
Last Update Posted:
2013-04-01
First Post:
2010-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-29', 'studyFirstSubmitDate': '2010-08-26', 'studyFirstSubmitQcDate': '2010-08-26', 'lastUpdatePostDateStruct': {'date': '2013-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endoscopic results of ulcer lesion', 'timeFrame': '56 days', 'description': 'Heal rate = (healed cases + significant improved cases)/total cases administered ×100 %'}, {'measure': 'Total effective rate', 'timeFrame': '56 days.', 'description': 'Total effective rate = (healed cases + significant improved cases + effective cases)/total cases administered ×100 %.'}], 'secondaryOutcomes': [{'measure': 'Symptoms improved level', 'timeFrame': '56 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Teprenone', 'safety', 'efficacy', 'acute gastric lesion', 'chronic gastritis'], 'conditions': ['Acute Gastritis', 'Gastric Ulcer']}, 'descriptionModule': {'briefSummary': 'This is a self-controlled, open, multiple-center clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n1. Age is over 18 years old , men or women\n2. Erosive lesions or flat lesions with thin white coating in acute gastritis, acute stage of chronic gastritis with over three lesions (including three lesions) by endoscopy prior to study in 3 days or diagnosed by clinical symptoms and signs;\n3. Signed the informed consent forms.\n\nExclusion criteria\n\n1. Patients without inclusion criteria\n2. Patients with significant cardiovascular, pulmonary, hepatic, renal or hemopoietic system primary disease\n3. Patients with other digestive diseases.\n4. Patients with operation on stomach and duodenum.\n5. Patients administered with nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids\n6. Patients with severity trauma, surgery, infection and shock.\n7. Patients with any kind of tumor\n8. Women either pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT01190657', 'briefTitle': 'Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eisai Inc.'}, 'officialTitle': 'A Multiple-center, Self-controlled Open Study to Evaluate Efficacy and Safety of Teprenone in Patients With Acute Gastritis, Acute Gastric Lesion of Chronic Gastritis With Acute Exacerbation or Gastric Ulcer', 'orgStudyIdInfo': {'id': 'P216'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Selbex 50mg (14 days)', 'interventionNames': ['Drug: Selbex']}, {'type': 'EXPERIMENTAL', 'label': 'Selbex 50mg (56 days)', 'interventionNames': ['Drug: Selbex']}], 'interventions': [{'name': 'Selbex', 'type': 'DRUG', 'description': '50mg/day, 3 times/day, for 14 days', 'armGroupLabels': ['Selbex 50mg (14 days)']}, {'name': 'Selbex', 'type': 'DRUG', 'description': '50mg/day, 3 times/day, for 56 days', 'armGroupLabels': ['Selbex 50mg (56 days)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': "Chinese People's Liberation Army General Hospital of Beijing Military", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'country': 'China', 'facility': "Chongqing First People's Hospital", 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Chongqing', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Hubei', 'country': 'China', 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 38.99842, 'lon': 112.01144}}, {'city': 'Hunan', 'country': 'China', 'facility': 'Changsha Central Hospital', 'geoPoint': {'lat': 28.71667, 'lon': 118.83333}}, {'city': 'Hunan', 'country': 'China', 'facility': "Hunan Provincial People's Hospital", 'geoPoint': {'lat': 28.71667, 'lon': 118.83333}}, {'city': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing First Hospital'}, {'city': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing General Hospital of Nanjing Military Command'}, {'city': 'Jiangsu', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Nanjing Medical University'}, {'city': 'Jiangsu', 'country': 'China', 'facility': 'The Second Affiliated Hospital of Suzhou University'}, {'city': 'Jiangsu', 'country': 'China', 'facility': "Wuxi #2 People's Hospital"}, {'city': 'Jilin', 'country': 'China', 'facility': 'Jilin University First Hospital', 'geoPoint': {'lat': 43.84652, 'lon': 126.5608}}, {'city': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital of China Medical University'}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Changzheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai First People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Renji Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Shanghai Ruijin Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Sixth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'country': 'China', 'facility': "Shanghai Tenth People's Hospital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanxi', 'country': 'China', 'facility': "Shanxi Provincial People's Hospital", 'geoPoint': {'lat': 44.00313, 'lon': 126.21057}}, {'city': 'Shanxi', 'country': 'China', 'facility': "The Second Affiliated Hospital of the Medical College of Xi'an Jiaotong University", 'geoPoint': {'lat': 44.00313, 'lon': 126.21057}}, {'city': 'Sichuan', 'country': 'China', 'facility': "Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital", 'geoPoint': {'lat': 35.1221, 'lon': 105.48032}}, {'city': 'Sichuan', 'country': 'China', 'facility': 'The Affiliated Hospital of Luzhou Medical College', 'geoPoint': {'lat': 35.1221, 'lon': 105.48032}}, {'city': 'Sichuan', 'country': 'China', 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 35.1221, 'lon': 105.48032}}, {'city': 'Zhejiang', 'country': 'China', 'facility': 'Hangzhou Red Cross Hospital', 'geoPoint': {'lat': 25.3238, 'lon': 105.583}}, {'city': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Zhejiang University', 'geoPoint': {'lat': 25.3238, 'lon': 105.583}}], 'overallOfficials': [{'name': 'Yaozong Yuan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eisai Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}