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China Survey of Peptic Ulcer Bleeding (PUB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01241266
First received: November 4, 2010
Last updated: December 29, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition
Peptic Ulcer Hemorrhage

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: China Survey of Peptic Ulcer Bleeding

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb). [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb) and receiving endoscopic treatment [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • The proportion of patients receiving endoscopic treatments by type of endoscopic treatmentendoscopic treatment [ Time Frame: 5 day ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 1044
Study Start Date: November 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hospitalized Patients

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241266

  Show 31 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Karen Atkin Astrazeneca China R&D
Principal Investigator: Zhaoshen Li Changhai Hospital
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01241266     History of Changes
Other Study ID Numbers: NIS-GCN-DUM-2010/1, D961DL00006
Study First Received: November 4, 2010
Last Updated: December 29, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by AstraZeneca:
Peptic Ulcer Bleeding
high risk
None-Interventional Study
he proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb)

Additional relevant MeSH terms:
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Pathologic Processes
Duodenal Diseases
 Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage

ClinicalTrials.gov processed this record on May 23, 2013