Upper Gastrointestinal BleedingNCT01155401
Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding
An observational study of Upper Gastrointestinal Bleeding, run by AstraZeneca at 1 site in Russia.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- Jun 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- 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.
Who cannot join
- Subjects who are unwilling or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- acute upper gastrointestinal bleeding, patients with drug-induced upper gastrointestinal bleeding, routine management
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with acute upper gastrointestinal bleeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of patients with drug-induced upper gastrointestinal bleeding
Measured: About 1 year
Secondary outcomes (3)
Number and percentage of patients with each symptom and each Forrest class of upper gastrointestinal bleeding
Measured: 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
Measured: About 1 year
Number and percentage of patients with each type of bleeding outcomes who received different types of hemostatic therapy
Measured: About 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal BleedingStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boris R Gelfand, Prof, Principal investigator, Department of the Russian State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155401
- Sponsor's protocol ID
- NIS-GRU-NEX-2009/2
- Status last verified
- Nov 2011
- First submitted
- 25 Jun 2010
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Incidence of Drug-induced Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT01155401
- Acronym / sponsor ID
- NIS-GRU-NEX-2009/2
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- acute upper gastrointestinal bleeding, patients with drug-induced upper gastrointestinal bleeding, routine management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients with acute upper gastrointestinal bleeding |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects who are unwilling or unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number and percentage of patients with drug-induced upper gastrointestinal bleeding
Time frame: About 1 year
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris R Gelfand, Prof principal investigator
Department of the Russian State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Gastrointestinal Bleeding, run by AstraZeneca at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of patients with drug-induced upper gastrointestinal bleeding (time frame: About 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.