Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00881413

Enrollment

Registered

2009-04-15

Start date

Unknown

Completion date

Unknown

Last updated

2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcer

Keywords

Peptic ulcer bleeding, Proton pump inhibitor, Esomeprazole, Pantoprazole, Recurrent bleeding, bleeding

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.

Interventions

DRUGEsomeprazole

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

DRUGPantoprazole

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
recurrent bleeding within 14 days of enrollment	14 days after enrollment

Secondary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026