Bleeding Clinical Trial
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)
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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