Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

NCT ID: NCT01155401

Last Updated: 2011-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Upper Gastrointestinal Bleeding

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with acute upper gastrointestinal bleeding

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boris R Gelfand, Prof

Role: PRINCIPAL_INVESTIGATOR

Department of the Russian State Medical University

Locations

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Research Site

Moscow, , Russia

Site Status

Countries

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Russia

Other Identifiers

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NIS-GRU-NEX-2009/2

Identifier Type: -

Identifier Source: org_study_id