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Trial record 7 of 69 for:    Open Studies | "Peptic Ulcer"
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Effect of IV and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy (IOE)

This study is currently recruiting participants.
Verified June 2010 by Chinese University of Hong Kong
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01142245
First received: June 9, 2010
Last updated: June 10, 2010
Last verified: June 2010
History of Changes
  Purpose

The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population.

The purpose of this clinical study is to compare the efficacy and safety of intravenous and oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent bleeding. The investigators hypothesize that using IV infusion is superior to oral PPI.


Condition Intervention Phase
Peptic Ulcer
Bleeding
 Drug: Oral esomeprazole
Drug: Intravenous Esomeprazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Effect of Intravenous and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy (IOE Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Rate of clinical rebleeding within 30 day of endoscopic therapy [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    Definition of clinical rebleeding

    1. Recurrent hematemesis
    2. fresh melena after normal stool
    3. Hypotension SBP<90 or tachycardia >110 AND fresh melena
    4. Decrease in Hb >2g/dL (or Hct > 6%) during any 24 h or an increas in Hb <1 g/dL (or Hct <3%) despite ≥2 units of blood has been transfused during any 24h


Secondary Outcome Measures:
  • Un-scheduled further endoscopic therapy [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    • Un-scheduled further endoscopic therapy
    • Need for surgery (i.e., operation rate)
    • Duration of hospitalization
    • Blood transfusion

  • Need for surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Duration of hospitalization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Blood transfusion [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • need of surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • un-scheduled further endoscopic therapy [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 406
Study Start Date: January 2008
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: oral esomeprazole
  • Esomeprazole placebo IV loading bolus
  • Esomeprazole placebo intravenous infusion for 72 hours
  • Oral Esomeprazole: 80 mg/Day on Day 1, 2 and Day 3, and the drug will be given as 40 mg q12h.
 Drug: Oral esomeprazole
• Oral Esomeprazole 40mg on Day 1, 2 and Day 3 q12h
Other Name: nexium
Active Comparator: Intravenous Esomeprazole

Esomeprazole IV loading bolus 80mg

• Esomeprazole intravenous infusion 8mg/hr for 72 hours

 Drug: Intravenous Esomeprazole

Esomeprazole IV 80mg loading bolus

  • Esomeprazole intravenous infusion 8mg/hr for 72 hours

Detailed Description:

The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population.

Endoscopic stigmata in bleeding peptic ulcers are prognostic and allow risk stratification. Patients with a clean ulcer base have a < 5% risk of rebleeding; this increases progressively with a flat spot, adherent clot, non-bleeding visible vessel and active bleeding (55%). Early endoscopy in patients with bleeding peptic ulcers selects the high risk ulcers for therapy and evaluation of adjuvant PPI use.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18
  • Confirmed ulcer bleeding with Forrest Ia, Ib, IIa, IIb
  • Endoscopic hemostasis achieved
  • Informed consent obtained

Exclusion Criteria:

  • No consent
  • Forrest II c, III (clear ulcer base/flat spot and no active bleeding, i.e., minimal risk for rebleeding)
  • Unsuccessful endoscopic treatment (i.e., injection and/or thermal coagulation for the initial bleeding) or severe bleeding that immediate surgery is indicated
  • Moribund patients in whom active treatment of any form is not considered.
  • Polytrauma, severe injury, unconsciousness, burns, or need for continuous artificial ventilation
  • Upper GI malignancy or disseminated malignant disease
  • Esophageal varices
  • A Mallory-Weiss lesion
  • Phenytoin or theophylline treatment
  • Uses of PPI or H2RAs within 3 days of admission, including uses at Emergency Department N.B. Usage of aspirin or NSAID is not an exclusion criteria.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01142245

Contacts
Contact: Bing Yee Suen, BHSc 526322931 suenbingyee@cuhk.edu.hk
Contact: Jessica YL Ching, MPH 26323524 jessicaching@cuhk.edu.hk

Locations
China, SAR
Endoscopy Centre Recruiting
Hong Kong, SAR, China, 852
Contact: Bing Yee Suen, BHS     26322931     suenbingyee@cuhk.edu.hk    
Contact: Jessica YL Ching, MPH     26323524     jessicching@cuhk.edu.hk    
Principal Investigator: Francis KL Chan, MD            
China
Endoscopy Center in Prince of Wales Hospital Recruiting
Hong Kong (SAR), China
Contact: Francis KL Chan, MD     852 2632 3143     fkl@cuhk.edu.hk    
Sponsors and Collaborators
Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Prof Joseph JY Sung, Institute of Digestive Disease
ClinicalTrials.gov Identifier: NCT01142245     History of Changes
Other Study ID Numbers: IOE
Study First Received: June 9, 2010
Last Updated: June 10, 2010
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
ulcer bleeding
endoscopic therapy

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

ClinicalTrials.gov processed this record on May 19, 2013