Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peptic Ulcer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Esomeprazole

High-dose esomeprazole

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

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

Pantoprazole

High-dose pantoprazole

Group Type ACTIVE_COMPARATOR

Pantoprazole

Intervention Type DRUG

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

Interventions

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Esomeprazole

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

Intervention Type DRUG

Pantoprazole

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

Intervention Type DRUG

Other Intervention Names

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Nexium Pantoloc

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No