Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

April 7, 2015 updated by: Lotung Poh-Ai Hospital

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Esomeprazole
High-dose esomeprazole
Drug: 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
Other Names:
  • Nexium
Active Comparator: Pantoprazole
High-dose pantoprazole
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
Other Names:
  • Pantoloc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
recurrent bleeding within 14 days of enrollment
Time Frame: 14 days after enrollment
14 days after enrollment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lotung Poh-Ai Hospital

Collaborators

Tomorrow Medical Foundation

Investigators

  • Principal Investigator: Hwai-jeng Lin, M.D., Lotung Poh-Ai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

April 13, 2009

First Submitted That Met QC Criteria

April 13, 2009

First Posted (Estimate)

April 15, 2009

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMCP98004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peptic Ulcer

Clinical Trials on Esomeprazole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe