Bleeding Peptic UlcerNCT01845168
Prevention of Gastric Ulcer Bleeding by Using "Computer-alert" in General Practice
A study testing Computer-alert and A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors in people with Bleeding Peptic Ulcer, run by Odense University Hospital at 2 sites in Denmark.
Trial summary
The purpose of this study is to investigate if a computerised decision-support tool used in general practice, can reduce the frequency of peptic ulcer bleeding related to the use of NSAIDs (Non-Steroidal-antiinflammatory-drug) and ASA( Acetylsalicylic acid) . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bleeding Peptic Ulcer
- What is being tested?
- Computer-alert and A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesDenmark
- Study dates
- Apr 2013to Apr 2015
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- General practitioners in the Region of Southern Denmark which are linked to Danish General Medical Database for minimum 6 months
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Johanna Petersen, MD contact
Jane Møller Hansen, MD, Ph.D contact
Denmark2 sites, 2 recruiting
- Recruiting
Afdeling for medicinske mavetarmsygdomme - Odense Universitetshospital
Odense, Funen, 5000
Johanna Petersen, MD, 0045 24379220, jmpetersen@health.sdu.dk
Johanna Petersen, MD
- Not yet recruiting
Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital
Odense
Johanna Petersen, jmpetersen@health.sdu.dk
Johanna Petersen
About this study
Official title: Prevention of Peptic Ulcer Bleeding Related to the Use of NSAIDs and Aspirin by Using "Computer-alert" - a Randomized Study in General Practice
The purpose of this study is to investigate if a computerised decision-support tool used in general practice, can reduce the frequency of peptic ulcer bleeding related to the use of NSAIDs (Non-Steroidal-antiinflammatory-drug) and ASA( Acetylsalicylic acid) .
On the basis of "The Danish general medical database" it is possible to develope a computerised decision-support tool, which enables the general practitioner (GP) in a "pop-up" window to get information on each patients risk-factors, when prescribing NSAID and aspirin to a patient at risk. This will give the general practitioner the oppurtunity to choose a different type of preparation or prescribe ulcer-preventive medicine at the same time.
The decision-support tool will be tested in a randomized trial among general practitioners. The aim is to reduce the occurence of peptic ulcer bleeding. The expected outcome is a reduction in half of the total numbers of peptic ulcers.
Read the detailed description
The background of the study is that NSAIDs and Aspirins increase the risk of peptic ulcer bleeding. On average 1-2% of patients using NSAID and Aspirin will develope gastric ulcer bleeding. But for patients with one or more risk-factors, the risk increases to 9% per 6 months. The mortality in this case is 10-15%. Approximately 3200 patients are admitted to the hospital with bleeding ulcer annually in Denmark.
Danish investigations have shown that 80% of all peptic ulcer bleedings admitted to hospital are related to the use of NSAID or Aspirin.
The consumption of NSAID and Aspirin is large. A third of people over 60 are treated within a year with these preparations. The risk of developing gastric ulcer related to NSAID and Aspirin can be reduced by concomitant therapy with antacids. Several studies have shown that only 20-30% of patients with risk-factors receive ulcer preventive medicine.
- Conditions
- Bleeding Peptic Ulcer
- Being tested
- Computer-alert, A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors
- Keywords
- Bleeding peptic ulcer, NSAID and Aspirin, Computer-alert, General practitioner
- Medical subject headings
- Peptic Ulcer Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-alertOther
A computer-alert which is activated when the physician is making a prescription for ASA or NSAID. Only for patients with riskfactors such as: Age over 60, males-gender, NSAID and ASA in kombination, Adenosine-diphosphate-inhibitor (ADP-inhibitor), blood-thinning medicine, Selective serotonin reuptake-inhibitor (SSRI) and steroids
A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factorsDevice
A computer-alert which is activated when the physician is making a prescription for ASA or NSAID. Only for patients with riskfactors such as: Age over 60, males-gender, NSAID and ASA in combination, ADP-inhibitor, bloodthinning medicine, SSRI, and steroids
Computer-alertDevice
| Study group | Role | What they receive |
|---|---|---|
| Computer-alert | Active comparator | 2 arm study active group: 'A computer alert which pops up when the GP prescribes NSAID/ASA to a patient with risk-factors Receives: Other: Computer-alert; Device: A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors; Device: Computer-alert |
| controlgroup, normal procedures | No intervention | The control-group: GP working in normal procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient outcome: The number of hospitalizations due to bleeding ulcer complication.
Measured: one year
Secondary outcomes (1)
Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2013
- Primary completionFeb 2014 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding Peptic UlcerStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark
- Responsible party
- Principal investigator, Johanna Petersen, Odense University Hospital
- Investigators
- Johanna Petersen, MD, Principal investigator, Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital.Jane M Hansen, MD, Ph.D, Study director, Afdeling for Medicinske mavetarmsygdommeJohanna M Petersen, MD, Principal investigator, Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01845168
- Sponsor's protocol ID
- S-20120034
- Status last verified
- Oct 2013
- First submitted
- 13 Mar 2013
- Last updated
- 29 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Peptic Ulcer Bleeding Related to the Use of NSAIDs and Aspirin by Using "Computer-alert" - a Randomized Study in General Practice
- ClinicalTrials.gov ID
- NCT01845168
- Acronym / sponsor ID
- S-20120034
- Conditions
- Bleeding Peptic Ulcer
- Keywords
- Bleeding peptic ulcer, NSAID and Aspirin, Computer-alert, General practitioner
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Region of Southern Denmark
- Study start
- Apr 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 3 May 2013 (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 investigate if a computerised decision-support tool used in general practice, can reduce the frequency of peptic ulcer bleeding related to the use of NSAIDs (Non-Steroidal-antiinflammatory-drug) and ASA( Acetylsalicylic acid) .
On the basis of "The Danish general medical database" it is possible to develope a computerised decision-support tool, which enables the general practitioner (GP) in a "pop-up" window to get information on each patients risk-factors, when prescribing NSAID and aspirin to a patient at risk. This will give the general practitioner the oppurtunity to choose a different type of preparation or prescribe ulcer-preventive medicine at the same time.
The decision-support tool will be tested in a randomized trial among general practitioners. The aim is to reduce the occurence of peptic ulcer bleeding. The expected outcome is a reduction in half of the total numbers of peptic ulcers.
Detailed description
The background of the study is that NSAIDs and Aspirins increase the risk of peptic ulcer bleeding. On average 1-2% of patients using NSAID and Aspirin will develope gastric ulcer bleeding. But for patients with one or more risk-factors, the risk increases to 9% per 6 months. The mortality in this case is 10-15%. Approximately 3200 patients are admitted to the hospital with bleeding ulcer annually in Denmark.
Danish investigations have shown that 80% of all peptic ulcer bleedings admitted to hospital are related to the use of NSAID or Aspirin.
The consumption of NSAID and Aspirin is large. A third of people over 60 are treated within a year with these preparations. The risk of developing gastric ulcer related to NSAID and Aspirin can be reduced by concomitant therapy with antacids. Several studies have shown that only 20-30% of patients with risk-factors receive ulcer preventive medicine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-alert | Active comparator | Other: Computer-alert, Device: A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors, Device: Computer-alert2 arm study active group: 'A computer alert which pops up when the GP prescribes NSAID/ASA to a patient with risk-factors |
| controlgroup, normal procedures | No intervention | –The control-group: GP working in normal procedures |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- General practitioners in the Region of Southern Denmark which are linked to Danish General Medical Database for minimum 6 months
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-alertA computer-alert which is activated when the physician is making a prescription for ASA or NSAID. Only for patients with riskfactors such as: Age over 60, males-gender, NSAID and ASA in kombination, Adenosine-diphosphate-inhibitor (ADP-inhibitor), blood-thinning medicine, Selective serotonin reuptake-inhibitor (SSRI) and steroids | Other | Computer-alert |
| A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factorsA computer-alert which is activated when the physician is making a prescription for ASA or NSAID. Only for patients with riskfactors such as: Age over 60, males-gender, NSAID and ASA in combination, ADP-inhibitor, bloodthinning medicine, SSRI, and steroids | Device | Computer-alert |
| Computer-alert | Device | Computer-alert |
Primary outcome
Patient outcome: The number of hospitalizations due to bleeding ulcer complication.
Time frame: one year
1 secondary outcome
Patient outcome: The number of uncomplicated ulcer diagnosed by endoscopy.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2013.
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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.
Johanna Petersen, MD contact
Jane Møller Hansen, MD, Ph.D contact
Johanna Petersen, MD principal investigator
Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital.
Jane M Hansen, MD, Ph.D study director
Afdeling for Medicinske mavetarmsygdomme
Johanna M Petersen, MD principal investigator
Afdeling for medicinske mavetarmsygdomme, Odense Universitetshospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-alert and A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors in people with Bleeding Peptic Ulcer, run by Odense University Hospital at 2 sites in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johanna Petersen, MD (jmpetersen@health.sdu.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient outcome: The number of hospitalizations due to bleeding ulcer complication. (time frame: one 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 29 Oct 2013.