Bleeding Peptic Ulcer Clinical Trial
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03551262 -
Over-the-scope Clip Versus Through-the-scope Clip for Endoscopic Hemostasis of High Risk Bleeding Peptic Ulcers
|
N/A | |
| Not yet recruiting |
NCT04170270 -
Oral Omeprazole in Bleeding Peptic Ulcer
|
Early Phase 1 | |
| Not yet recruiting |
NCT06196710 -
The Use of OTSC in LBGDU to Standard Endoscopic Hemostatic Methods
|
N/A | |
| Completed |
NCT01675856 -
Urgent vs. Early Endoscopy in High Risk Patients With Upper Gastrointestinal Bleeding (UGIB)
|
N/A | |
| Recruiting |
NCT00164827 -
Surveillance of Bleeding Peptic Ulcer Using Wireless Capsule Endoscopy
|
Phase 3 | |
| Completed |
NCT04366583 -
Argon Plasma Coagulation vs Hemoclipping for Bleeding Peptic Ulcers
|
Phase 4 | |
| Completed |
NCT01757275 -
High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a Bleeding Peptic Ulcer
|
Phase 3 | |
| Completed |
NCT02245802 -
Multicenter Validation on Predicting Mortality for Patients With Bleeding Peptic Ulcers
|
N/A |