Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the clinical effectiveness of intravenous esomeprazole and pantoprazole in preventing recurrent bleeding in the patients with high-risk bleeding peptic ulcers after successful standard endoscopic hemostasis.

Detailed Description
-----------------
Endoscopic hemostasis and proton pump inhibitor (PPI) constitute the cornerstone in the management of peptic ulcer bleeding (PUB), which remains a prevalent disorder associated with substantial morbidity and mortality. Clinical effectiveness of PPI in the management of patients with PUB has been established by compelling evidence derived from a number of randomized trials. However, whether different PPIs are equally effective has not been investigated. Esomeprazole, the S-isomer of omeprazole, may achieve faster, more profound and steady acid suppression than other PPIs, but it remains undetermined whether the superiority of pharmacologic efficacy may be translated into advantages in clinical outcomes.

Official Title
-----------------
Clinical Effectiveness of Intravenous Esomeprazole Versus Pantoprazole in Preventing Peptic Ulcer Recurrent Bleeding: a Double-Blind Randomized Trial

Conditions
-----------------
Peptic Ulcer

Intervention / Treatment
-----------------
* Drug: Esomeprazole
* Drug: Pantoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged more than 18 years undergo emergent endoscopy within 24 hours of presentation have peptic ulcers in the gastroesophageal junction, stomach, or duodenum high-risk stigmata of peptic ulcers: Forrest classification IA IIB endoscopic hemostasis by thermocoagulation or clip placement Exclusion Criteria: pregnant or lactating written informed consent not obtained initial endoscopic hemostasis fail bleeding tendency (platelet count < 50×109/L, prolonged prothrombin time for more than 3 seconds, or were taking anticoagulants) PPI use within 14 days of enrollment comorbid with severe hepatic or renal insufficiency (serum total bilirubin more than 5 mg/dL, serum creatinine more than 5 mg/dL, or under dialysis) bleeding gastric cancers

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Experimental: Esomeprazole<br>High-dose esomeprazole | Drug: Esomeprazole<br>* Intravenous esomeprazole (Nexium®, AstraZeneca, Sodertalje, Sweden) is administered with 80mg bolus and 8mg/hr infusion for 72 hours. After 3 days, patients receive oral esomeprazole 40 mg (Nexium®, AstraZeneca, Sodertalje, Sweden) for 2 months<br>* Other names: Nexium;|
| Active Comparator: Pantoprazole<br>High-dose pantoprazole | Drug: Pantoprazole<br>* After successful endoscopy, intravenous pantoprazole (Pantoloc®, Nycomed GMBH, Konstanz, Germany) is administered with 80mg bolus and 8mg/hr infusion for 72 hours. After 3 days, patients receive oral pantoprazole 40 mg (Pantoloc®, Nycomed GMBH, Oranienburg, Germany) for 2 months<br>* Other names: Pantoloc;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrent bleeding within 14 days of enrollment |  | 14 days after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of blood transfusion |  | 14 days after enrollment | 
| Need for surgery |  | 14 days after enrollment | 
| all-cause mortality |  | 14 days after enrollment | 
| bleeding-related mortality |  | 14 days after enrollment | 
| length of hospital stay |  | probably one month after enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peptic ulcer bleeding, Proton pump inhibitor, Esomeprazole, Pantoprazole, Recurrent bleeding, bleeding