Clinical Trial: Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Clinical Effectiveness of Intravenous Esomeprazole Versus Pantoprazole in Preventing Peptic Ulcer Recurrent Bleeding: a Double-Blind Randomized Trial

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Lotung Poh-Ai Hospital

Current Primary Outcome: recurrent bleeding within 14 days of enrollment [ Time Frame: 14 days after enrollment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Volume of blood transfusion [ Time Frame: 14 days after enrollment ]
  • Need for surgery [ Time Frame: 14 days after enrollment ]
  • all-cause mortality [ Time Frame: 14 days after enrollment ]
  • bleeding-related mortality [ Time Frame: 14 days after enrollment ]
  • length of hospital stay [ Time Frame: probably one month after enrollment ]


Original Secondary Outcome: Same as current

Information By: Lotung Poh-Ai Hospital

Dates:
Date Received: April 13, 2009
Date Started:
Date Completion:
Last Updated: April 7, 2015
Last Verified: April 2009