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Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01155401
First received: June 25, 2010
Last updated: November 7, 2011
Last verified: November 2011
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number and percentage of patients with each symptom and each Forrest class of upper gastrointestinal bleeding [ Time Frame: About 1 year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Number and percentage of patients with each type of bleeding outcomes who received different types of hemostatic therapy [ Time Frame: About 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01155401     History of Changes
Other Study ID Numbers: NIS-GRU-NEX-2009/2
Study First Received: June 25, 2010
Last Updated: November 7, 2011
Health Authority: Russia: Ethics Committee

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

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

ClinicalTrials.gov processed this record on June 17, 2013