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Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01155401
First Posted: July 1, 2010
Last Update Posted: November 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
The purpose of this study is to determine and analyse the incidence, severity, risk factors and routine management of acute drug-induced upper gastrointestinal bleeding (UGIB) in the population of Russian patients

Condition
Upper Gastrointestinal Bleeding

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number and percentage of patients with drug-induced upper gastrointestinal bleeding [ Time Frame: About 1 year ]

Secondary Outcome Measures:
  • Number and percentage of patients with each symptom and each Forrest class of upper gastrointestinal bleeding [ Time Frame: About 1 year ]
  • Number and percentage of patients with concomitant diseases contributing to drug-induced upper gastrointestinal bleeding and those who receive NSAIDs, antiplatelet agents, anticoagulants, steroids or combination therapy [ Time Frame: About 1 year ]
  • Number and percentage of patients with each type of bleeding outcomes who received different types of hemostatic therapy [ Time Frame: About 1 year ]

Enrollment: 300
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with acute upper gastrointestinal bleeding

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
Primary Care Clinic
Criteria

Inclusion Criteria:

  • Established diagnosis of acute upper gastrointestinal bleeding, confirmed by presence of hematemesis/ coffee ground vomiting, melena, as well as other clinical or laboratory evidence of acute blood loss from the upper gastrointestinal tract
  • Written informed consent provided prior the start of participation in the study.

Exclusion Criteria:

  • Subjects who are unwilling or unable to provide informed consent.
  Contacts and Locations
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): NCT01155401


Locations
Russian Federation
Research Site
Moscow, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Boris R Gelfand, Prof Department of the Russian State Medical University
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01155401     History of Changes
Other Study ID Numbers: NIS-GRU-NEX-2009/2
First Submitted: June 25, 2010
First Posted: July 1, 2010
Last Update Posted: November 8, 2011
Last Verified: November 2011

Keywords provided by AstraZeneca:
acute upper gastrointestinal bleeding
patients with drug-induced upper gastrointestinal bleeding
routine management

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases