search
Back to results

Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

Primary Purpose

Peptic Ulcer

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Esomeprazole
Pantoprazole
Sponsored by
Lotung Poh-Ai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcer focused on measuring Peptic ulcer bleeding, Proton pump inhibitor, Esomeprazole, Pantoprazole, Recurrent bleeding, bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Esomeprazole

    Pantoprazole

    Arm Description

    High-dose esomeprazole

    High-dose pantoprazole

    Outcomes

    Primary Outcome Measures

    recurrent bleeding within 14 days of enrollment

    Secondary Outcome Measures

    Volume of blood transfusion
    Need for surgery
    all-cause mortality
    bleeding-related mortality
    length of hospital stay

    Full Information

    First Posted
    April 13, 2009
    Last Updated
    April 7, 2015
    Sponsor
    Lotung Poh-Ai Hospital
    Collaborators
    Tomorrow Medical Foundation
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00881413
    Brief Title
    Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding
    Official Title
    Clinical Effectiveness of Intravenous Esomeprazole Versus Pantoprazole in Preventing Peptic Ulcer Recurrent Bleeding: a Double-Blind Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2009
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    problems in funding
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Lotung Poh-Ai Hospital
    Collaborators
    Tomorrow Medical Foundation

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peptic Ulcer
    Keywords
    Peptic ulcer bleeding, Proton pump inhibitor, Esomeprazole, Pantoprazole, Recurrent bleeding, bleeding

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Esomeprazole
    Arm Type
    Experimental
    Arm Description
    High-dose esomeprazole
    Arm Title
    Pantoprazole
    Arm Type
    Active Comparator
    Arm Description
    High-dose pantoprazole
    Intervention Type
    Drug
    Intervention Name(s)
    Esomeprazole
    Other Intervention Name(s)
    Nexium
    Intervention Description
    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
    Intervention Name(s)
    Pantoprazole
    Other Intervention Name(s)
    Pantoloc
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    recurrent bleeding within 14 days of enrollment
    Time Frame
    14 days after enrollment
    Secondary Outcome Measure Information:
    Title
    Volume of blood transfusion
    Time Frame
    14 days after enrollment
    Title
    Need for surgery
    Time Frame
    14 days after enrollment
    Title
    all-cause mortality
    Time Frame
    14 days after enrollment
    Title
    bleeding-related mortality
    Time Frame
    14 days after enrollment
    Title
    length of hospital stay
    Time Frame
    probably one month after enrollment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hwai-Jeng Lin, M.D.
    Organizational Affiliation
    Lotung Poh-Ai Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19221370
    Citation
    Sung JJ, Barkun A, Kuipers EJ, Mossner J, Jensen DM, Stuart R, Lau JY, Ahlbom H, Kilhamn J, Lind T; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):455-64. doi: 10.7326/0003-4819-150-7-200904070-00105. Epub 2009 Feb 16.
    Results Reference
    background

    Learn more about this trial

    Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

    We'll reach out to this number within 24 hrs