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China Survey of Peptic Ulcer Bleeding (PUB)

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ClinicalTrials.gov Identifier: NCT01241266
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : December 30, 2011
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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.

Condition or disease
Peptic Ulcer Hemorrhage

Study Type : Observational
Actual Enrollment : 1044 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: China Survey of Peptic Ulcer Bleeding
Study Start Date : November 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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



Primary Outcome Measures :
  1. The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb). [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. The proportion of peptic ulcer bleeding patients who are at high risk (Forrest Ia-IIb) and receiving endoscopic treatment [ Time Frame: 1 day ]
  2. The proportion of patients receiving endoscopic treatments by type of endoscopic treatmentendoscopic treatment [ Time Frame: 5 day ]
  3. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241266


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01241266     History of Changes
Other Study ID Numbers: NIS-GCN-DUM-2010/1
D961DL00006
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: December 30, 2011
Last Verified: December 2011

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:
Ulcer
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage