Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding | RxWiki

Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Peptic Ulcer
Intervention	Drug: Esomeprazole Drug: Pantoprazole
Phase	Phase 4
Sponsor	Lotung Poh-Ai Hospital
Responsible Party	Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier	NCT00881413
First Received	April 13, 2009
Last Updated	April 22, 2009
Last verified	April 2009

Tracking Information[ + expand ][ + ]

First Received Date	April 13, 2009
Last Updated Date	April 22, 2009
Start Date	Not Provided
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	recurrent bleeding within 14 days of enrollment [Time Frame: 14 days after enrollment] [Designated as safety issue: No]
Current Secondary Outcome Measures	Volume of blood transfusion [Time Frame: 14 days after enrollment] [Designated as safety issue: No] Need for surgery [Time Frame: 14 days after enrollment] [Designated as safety issue: No] all-cause mortality [Time Frame: 14 days after enrollment] [Designated as safety issue: No] bleeding-related mortality [Time Frame: 14 days after enrollment] [Designated as safety issue: No] length of hospital stay [Time Frame: probably one month after enrollment] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	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
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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Condition	Peptic 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 Other Names: NexiumDrug: 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 Other Names: Pantoloc
Study Arm (s)	Experimental: Esomeprazole High-dose esomeprazole Active Comparator: Pantoprazole High-dose pantoprazole

Recruitment Information[ + expand ][ + ]

Recruitment Status	Withdrawn
Estimated Enrollment	600
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	Not Provided
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00881413
Other Study ID Numbers	OMCP98004
Has Data Monitoring Committee	No
Information Provided By	Lotung Poh-Ai Hospital
Study Sponsor	Lotung Poh-Ai Hospital
Collaborators	Tomorrow Medical Foundation
Investigators	Principal Investigator: Hwai-Jeng Lin, M.D. Lotung Poh-Ai Hospital
Verification Date	April 2009