- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01155401
Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding
November 7, 2011 updated by: AstraZeneca
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Moscow, Russian Federation
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Primary Care Clinic
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Patients with acute upper gastrointestinal bleeding
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number and percentage of patients with drug-induced upper gastrointestinal bleeding
Time Frame: About 1 year
|
About 1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number and percentage of patients with each symptom and each Forrest class of upper gastrointestinal bleeding
Time Frame: About 1 year
|
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
|
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
|
About 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Boris R Gelfand, Prof, Department of the Russian State Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
June 1, 2011
Study Registration Dates
First Submitted
June 25, 2010
First Submitted That Met QC Criteria
June 30, 2010
First Posted (Estimate)
July 1, 2010
Study Record Updates
Last Update Posted (Estimate)
November 8, 2011
Last Update Submitted That Met QC Criteria
November 7, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-GRU-NEX-2009/2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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