Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2026-01-01 @ 10:01 AM
Study NCT ID:
NCT01241266
Status:
COMPLETED
Last Update Posted:
2011-12-30
First Post:
2010-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Survey of Peptic Ulcer Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010438', 'term': 'Peptic Ulcer Hemorrhage'}], 'ancestors': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1044}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-29', 'studyFirstSubmitDate': '2010-11-04', 'studyFirstSubmitQcDate': '2010-11-12', 'lastUpdatePostDateStruct': {'date': '2011-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb).', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb) and receiving endoscopic treatment', 'timeFrame': '1 day'}, {'measure': 'The proportion of patients receiving endoscopic treatments by type of endoscopic treatmentendoscopic treatment', 'timeFrame': '5 day'}, {'measure': 'The clinically significant re-bleeding rate of high risk (Forrest Ia-IIb) peptic ulcer bleeding patients treated with or without PPI or H2RA, at 3, 5 and 30 days after successful endoscopy treatment.', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Peptic Ulcer Bleeding', 'high risk', 'None-Interventional Study', 'he proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb)'], 'conditions': ['Peptic Ulcer Hemorrhage']}, 'descriptionModule': {'briefSummary': 'This will be a multicenter prospective observational study carried out in China. The investigators will collect data in a pre-specified Case Report Form. Main data from each patient will include demographics, endoscopy classification, and both endoscopy and pharmacological treatments received by patients. Data from each patient will be prospectively collected from the day the patient is diagnosed as peptic ulcer bleeding by endoscopy and receives endoscopy treatment if the investigator thinks it is needed and up to 30 days afterwards. The proportion of peptic ulcer bleeding patients who are at high risk is the primary outcome variable. High risk is defined as the patients with endoscopy Forrest classification Ia to IIb. The rate and type of endoscopic treatment, the rate of successful endoscopy treatment, the re-bleeding rate and the endoscopic re-treatment rate in high risk peptic ulcer bleeding patients will be collected. The surgery rate and mortality rate in high risk and overall patient population will be calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Hospitalized Patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female and/or male aged 18 years and above\n* Admitted to the hospital with an overt upper GI bleeding (hematemesis/coffee ground vomiting, melena, hematochezia and other clinical or laboratory evidence of acute blood loss from the upper GI tract)\n* Endoscopy demonstrated peptic ulcer bleeding (Forrest I-III)\n\nExclusion Criteria:\n\n* If participating in any clinical trial, the subject cannot take part in this study.'}, 'identificationModule': {'nctId': 'NCT01241266', 'acronym': 'PUB', 'briefTitle': 'China Survey of Peptic Ulcer Bleeding', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'China Survey of Peptic Ulcer Bleeding', 'orgStudyIdInfo': {'id': 'NIS-GCN-DUM-2010/1'}, 'secondaryIdInfos': [{'id': 'D961DL00006'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Target subject population are the consecutive patients hospitalized due to peptic ulcer bleeding. Subjects should be: ≥18 years; admitted to the hospital with an overt upper GI bleed (hematemesis/coffee ground vomiting, melena, hematochezia and other clin'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}, {'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Xiamen', 'state': 'Fujian', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 24.47979, 'lon': 118.08187}}, {'city': 'Lanzhou', 'state': 'Gansu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': 'Haerbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Research Site'}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Jiangyin', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.91102, 'lon': 120.26302}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Nantong', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.03028, 'lon': 120.87472}}, {'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Hohhot', 'state': 'Neimeng', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Taiyuan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}, {'city': 'Xian', 'state': 'Shanxi', 'country': 'China', 'facility': 'Research Site'}, {'city': 'Yangquan', 'state': 'Shanxi', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 37.8575, 'lon': 113.56333}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Ürümqi', 'state': 'Xinjiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 43.80096, 'lon': 87.60046}}, {'city': 'Kunming', 'state': 'Yunnan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}, {'city': 'Fuyang', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.05333, 'lon': 119.95194}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Jinhua', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 29.10678, 'lon': 119.64421}}, {'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'overallOfficials': [{'name': 'Karen Atkin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astrazeneca China R&D'}, {'name': 'Zhaoshen Li', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}