Clinical trial NCT01142245: Effect of IV and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peptic Ulcer
Bleeding
Keywords: ulcer bleeding
endoscopic therapy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2010-06-11
Enrollment: 263
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Rate of clinical rebleeding within 30 day of endoscopic therapy
timeFrame: 30 days
Secondary outcomes:
measure: Un-scheduled further endoscopic therapy
timeFrame: 30 days
measure: Need for surgery
timeFrame: 30 days
measure: Duration of hospitalization
timeFrame: 30 days
measure: Blood transfusion
timeFrame: 30 days
measure: mortality
timeFrame: 30 days
measure: need of surgery
timeFrame: 30 days
measure: un-scheduled further endoscopic therapy
timeFrame: 30 days
Other outcomes:
Locations:
city: Hong Kong (SAR)
country: China
facility: Endoscopy Center in Prince of Wales Hospital
city: Hong Kong
country: China
facility: Endoscopy Centre
Study officials:
affiliation: CUHK
name: Francis K Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: