Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding
- Registration Number
- NCT00881413
- Lead Sponsor
- Lotung Poh-Ai Hospital
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pantoprazole Pantoprazole High-dose pantoprazole Esomeprazole Esomeprazole High-dose esomeprazole
- Primary Outcome Measures
Name Time Method recurrent bleeding within 14 days of enrollment 14 days after enrollment
- Secondary Outcome Measures
Name Time Method Volume of blood transfusion 14 days after enrollment Need for surgery 14 days after enrollment all-cause mortality 14 days after enrollment length of hospital stay probably one month after enrollment bleeding-related mortality 14 days after enrollment