China Survey of Peptic Ulcer Bleeding

Peptic Ulcer Hemorrhage Clinical Trial

— PUB  

Official title:

China Survey of Peptic Ulcer Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01241266
• Other study ID #: NIS-GCN-DUM-2010/1
• Secondary ID: D961DL00006
• Status: Completed
• Phase: N/A
• First received: November 4, 2010
• Last updated: December 29, 2011
• Start date: November 2010
• Est. completion date: July 2011

Study information

• Verified date: December 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1044
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female and/or male aged 18 years and above

• 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)

• Endoscopy demonstrated peptic ulcer bleeding (Forrest I-III)

Exclusion Criteria:

• If participating in any clinical trial, the subject cannot take part in this study.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Changchun	Jilin
China	Research Site	Changsha	Hunan
China	Research Site	Chengdu	Sichuan
China	Research Site	Chongqing	Chongqing
China	Research Site	Fuyang	Zhejiang
China	Research Site	Fuzhou	Fujian
China	Research Site	Guangzhou	Guangdong
China	Research Site	Haerbin	Heilongjiang
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Hefei	Anhui
China	Research Site	Huhehaote	Neimeng
China	Research Site	Jiangyin	Jiangsu
China	Research Site	Jinan	Shandong
China	Research Site	Jinhua	Zhejiang
China	Research Site	Kunming	Yunnan
China	Research Site	Lanzhou	Gansu
China	Research Site	Nanchang	Jiangxi
China	Research Site	Nanjing	Jiangsu
China	Research Site	Nantong	Jiangsu
China	Research Site	Shanghai	Shanghai
China	Research Site	Shenyang	Liaoning
China	Research Site	Shenzhen	Guangdong
China	Research Site	Taiyuan	Shanxi
China	Research Site	Tianjin	Tianjin
China	Research Site	Wenzhou	Zhejiang
China	Research Site	Wuhan	Hubei
China	Research Site	Wulumuqi	Xinjiang
China	Research Site	Xiamen	Fujian
China	Research Site	Xian	Shanxi
China	Research Site	Yangquan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb).		1 day	No
Secondary	The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb) and receiving endoscopic treatment		1 day	No
Secondary	The proportion of patients receiving endoscopic treatments by type of endoscopic treatmentendoscopic treatment		5 day	No
Secondary	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.		30 days	No