Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

Lotung Poh-Ai Hospital

Status and phase

Withdrawn

Phase 4

Conditions

Peptic Ulcer

Treatments

Drug: Esomeprazole

Drug: Pantoprazole

Study type

Interventional

Funder types

Other

Identifiers

NCT00881413

OMCP98004

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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