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NCT Number: NCT01142245

Effect of IV and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Endoscopy Centre, Hong Kong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral esomeprazole

Drug
  • Oral Esomeprazole 40mg on Day 1, 2 and Day 3 q12h

Other names: oral, nexium

Intravenous Esomeprazole

Drug

Esomeprazole IV 80mg loading bolus

  • Esomeprazole intravenous infusion 8mg/hr for 72 hours

Other names: IV, nexium

Primary outcomes

  1. Rate of clinical rebleeding within 30 day of endoscopic therapy

    Time frame: 30 days

    Definition of clinical rebleeding

    • Recurrent hematemesis
    • fresh melena after normal stool
    • Hypotension SBP<90 or tachycardia >110 AND fresh melena
    • Decrease in Hb >2g/dL (or Hct > 10%) during any 24 h or an increas in Hb <1 g/dL (or Hct <3%) despite ≥4 units of blood has been transfused during any 48h

Secondary outcomes

  1. Un-scheduled further endoscopic therapy

    Time frame: 30 days

    • Un-scheduled further endoscopic therapy
    • Need for surgery (i.e., operation rate)
    • Duration of hospitalization
    • Blood transfusion
  2. Need for surgery

    Time frame: 30 days

  3. Duration of hospitalization

    Time frame: 30 days

  4. Blood transfusion

    Time frame: 30 days

  5. mortality

    Time frame: 30 days

  6. need of surgery

    Time frame: 30 days

  7. un-scheduled further endoscopic therapy

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Phase 3 Study of Effect of Intravenous and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy (IOE Study)

Acronym: IOE

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Jun 11, 2010
Registry last updated
Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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