Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

This study has been withdrawn prior to enrollment.
(problems in funding)
Sponsor:
Collaborator:
Tomorrow Medical Foundation
Information provided by:
Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier:
NCT00881413
First received: April 13, 2009
Last updated: April 22, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Peptic Ulcer
Drug: Esomeprazole
Drug: Pantoprazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Clinical Effectiveness of Intravenous Esomeprazole Versus Pantoprazole in Preventing Peptic Ulcer Recurrent Bleeding: a Double-Blind Randomized Trial

Resource links provided by NLM:


Further study details as provided by Lotung Poh-Ai Hospital:

Primary Outcome Measures:
  • recurrent bleeding within 14 days of enrollment [ Time Frame: 14 days after enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Volume of blood transfusion [ Time Frame: 14 days after enrollment ] [ Designated as safety issue: No ]
  • Need for surgery [ Time Frame: 14 days after enrollment ] [ Designated as safety issue: No ]
  • all-cause mortality [ Time Frame: 14 days after enrollment ] [ Designated as safety issue: No ]
  • bleeding-related mortality [ Time Frame: 14 days after enrollment ] [ Designated as safety issue: No ]
  • length of hospital stay [ Time Frame: probably one month after enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Arms Assigned Interventions
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 Name: 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 Name: Pantoloc

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881413

Sponsors and Collaborators
Lotung Poh-Ai Hospital
Tomorrow Medical Foundation
Investigators
Principal Investigator: Hwai-Jeng Lin, M.D. Lotung Poh-Ai Hospital
  More Information

Publications:
Responsible Party: Professor Hwai-Jeng Lin, Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier: NCT00881413     History of Changes
Other Study ID Numbers: OMCP98004
Study First Received: April 13, 2009
Last Updated: April 22, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by Lotung Poh-Ai Hospital:
Peptic ulcer bleeding
Proton pump inhibitor
Esomeprazole
Pantoprazole
Recurrent bleeding
bleeding

Additional relevant MeSH terms:
Ulcer
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esomeprazole
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014