Ignite Creation Date:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2026-01-04 @ 4:01 AM
Study NCT ID:
NCT01845168
Status:
UNKNOWN
Last Update Posted:
2013-10-29
First Post:
2013-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Gastric Ulcer Bleeding by Using "Computer-alert" in General Practice
Sponsor:
Odense University Hospital
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2013-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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) .
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: