Comparison of Low Against High Regimen of Proton Pump Inhibitors for Treatment of Acute Peptic Ulcer Bleeding

Study Overview
=================
Brief Summary
-----------------
Evaluate the efficacy of Two different regimens of proton pump inhibitors High against Low in the management of acute peptic ulcer bleeding

Detailed Description
-----------------
Evaluate the efficacy of Two different regimens of proton pump inhibitors in the management of acute peptic ulcer bleeding First: loading dose 80 mg then 8mg/h iv continuous infusion for 3 days Second Loading dose 80 mg the 40 mg every 12 h for 3 days

Official Title
-----------------
Low Dose Against High Dose of Proton Pump Inhibitors in Treatment Acute Peptic Ulcer Bleeding

Conditions
-----------------
Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage

Intervention / Treatment
-----------------
* Drug: Omeprazole High dose
* Drug: Omeprazole Low dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High risk ulcers defined according to the Forrest classification With respect to high-risk stigmata, active bleeding was defined as a continuous blood spurting (Forrest IA) oozing (Forrest IB) from the ulcer base. A non-bleeding visible vessel at endoscopy was defined as a discrete protuberance at the ulcer base(Forrest IIA). An adherent clot was one that was resistant to forceful irrigation or suction (Forrest IIB). Exclusion Criteria: ulcer was malignant non ulcerative bleeding such as angiodysplasia , a Mallory-Weiss tear....

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Omeprazole High dose<br>Omeprazole 80 mg loading dose,then 8mg/h IV continuous infusion for 3 days | Drug: Omeprazole High dose<br>* High regimen of Proton Pump Inhibitors in treatment of bleeding ulcer 80 mg loading dose then 8 mg/h iv for 3 days<br>|
| Experimental: Omeprazole Low Dose<br>Omeprazole 80 mg loading dose IV then 40 mg two times per day IV for 3 days | Drug: Omeprazole Low dose<br>* low regimen of Proton Pump Inhibitors in treatment bleeding ulcer 80 mg loading dose then 40 mg two times per day for 3 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding | recurrent melena (black, tarry stool) or recurrent Hematemesis or coffee-ground emesis or recurrent hematochezia after begin treatment | one month | 
| Surgery | need for surgery | one month | 
| Length of hospital stay |  | one month | 
| Blood transfusions | number of transfusion blood unites during admission | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroduodenal Ulcer, Marginal Ulcer, Peptic Ulcer Hemorrhage, Peptic Ulcer