Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

Peptic Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00881413
• Other study ID #: OMCP98004
• Status: Withdrawn
• Phase: Phase 4
• First received: April 13, 2009
• Last updated: April 7, 2015

Study information

• Verified date: April 2009
• Source: Lotung Poh-Ai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peptic Ulcer
• Ulcer

Intervention

Drug:
• Esomeprazole
Intravenous esomeprazole (Nexium®, AstraZeneca, Sodertalje, Sweden) is administered with 80mg bolus and 8mg/hr infusion for 72 hours. After 3 days, patients receive oral esomeprazole 40 mg (Nexium®, AstraZeneca, Sodertalje, Sweden) for 2 months
• Pantoprazole
After successful endoscopy, intravenous pantoprazole (Pantoloc®, Nycomed GMBH, Konstanz, Germany) is administered with 80mg bolus and 8mg/hr infusion for 72 hours. After 3 days, patients receive oral pantoprazole 40 mg (Pantoloc®, Nycomed GMBH, Oranienburg, Germany) for 2 months

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Lotung Poh-Ai Hospital	Tomorrow Medical Foundation

References & Publications (1)

Sung JJ, Barkun A, Kuipers EJ, Mössner 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. Epub 2009 Feb 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrent bleeding within 14 days of enrollment		14 days after enrollment	No
Secondary	Volume of blood transfusion		14 days after enrollment	No
Secondary	Need for surgery		14 days after enrollment	No
Secondary	all-cause mortality		14 days after enrollment	No
Secondary	bleeding-related mortality		14 days after enrollment	No
Secondary	length of hospital stay		probably one month after enrollment	No