Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

Upper Gastrointestinal Bleeding Clinical Trial

Official title:

Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155401
• Other study ID #: NIS-GRU-NEX-2009/2
• Status: Completed
• Phase: N/A
• First received: June 25, 2010
• Last updated: November 7, 2011
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: November 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Locations

Country	Name	City	State
Russian Federation	Research Site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and percentage of patients with drug-induced upper gastrointestinal bleeding		About 1 year	No
Secondary	Number and percentage of patients with each symptom and each Forrest class of upper gastrointestinal bleeding		About 1 year	No
Secondary	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		About 1 year	No
Secondary	Number and percentage of patients with each type of bleeding outcomes who received different types of hemostatic therapy		About 1 year	No