Clinical trial NCT00881413: Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding
Official title: Clinical Effectiveness of Intravenous Esomeprazole Versus Pantoprazole in Preventing Peptic Ulcer Recurrent Bleeding: a Double-Blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Peptic Ulcer
Keywords: Peptic ulcer bleeding
Proton pump inhibitor
Esomeprazole
Pantoprazole
Recurrent bleeding
bleeding
Lead sponsor: Lotung Poh-Ai Hospital
Sponsor class: OTHER
Collaborators: name: Tomorrow Medical Foundation
First posted: 2009-04-15
Enrollment: 0
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 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 description: 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.

Eligibility criteria: Inclusion Criteria:

* aged more than 18 years
* undergo emergent endoscopy within 24 hours of presentation
* have peptic ulcers in the gastroesophageal junction, stomach, or duodenum
* high-risk stigmata of peptic ulcers: Forrest classification IA\~IIB
* endoscopic hemostasis by thermocoagulation or clip placement

Exclusion Criteria:

* pregnant or lactating
* written informed consent not obtained
* initial endoscopic hemostasis fail
* bleeding tendency (platelet count \< 50×109/L, prolonged prothrombin time for more than 3 seconds, or were taking anticoagulants)
* PPI use within 14 days of enrollment
* comorbid with severe hepatic or renal insufficiency (serum total bilirubin more than 5 mg/dL, serum creatinine more than 5 mg/dL, or under dialysis)
* bleeding gastric cancers

Primary outcomes:
measure: recurrent bleeding within 14 days of enrollment
timeFrame: 14 days after enrollment
Secondary outcomes:
measure: Volume of blood transfusion
timeFrame: 14 days after enrollment
measure: Need for surgery
timeFrame: 14 days after enrollment
measure: all-cause mortality
timeFrame: 14 days after enrollment
measure: bleeding-related mortality
timeFrame: 14 days after enrollment
measure: length of hospital stay
timeFrame: probably one month after enrollment
Other outcomes:
Locations:
Study officials:
affiliation: Lotung Poh-Ai Hospital
name: Hwai-Jeng Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sung JJ, Barkun A, Kuipers EJ, Mossner J, Jensen DM, Stuart R, Lau JY, Ahlbom H, Kilhamn J, Lind T; Peptic Ulcer Bleed Study Group. Intravenous esomeprazole for prevention of recurrent peptic ulcer bleeding: a randomized trial. Ann Intern Med. 2009 Apr 7;150(7):455-64. doi: 10.7326/0003-4819-150-7-200904070-00105. Epub 2009 Feb 16.