Esomeprazole Versus Pantoprazole to Prevent Peptic Ulcer Rebleeding

NCT00881413 | Withdrawn Phase 4

• 1 other identifier: OMCP98004
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peptic Ulcer

Keywords

Peptic ulcer bleeding; Proton pump inhibitor; Esomeprazole; Pantoprazole; Recurrent bleeding; bleeding

Outcome Measures

Primary Outcomes (1)

• recurrent bleeding within 14 days of enrollment

  14 days after enrollment

Secondary Outcomes (5)

• Volume of blood transfusion

  14 days after enrollment

• Need for surgery

  14 days after enrollment

• all-cause mortality

  14 days after enrollment

• bleeding-related mortality

  14 days after enrollment

• length of hospital stay

  probably one month after enrollment

Study Arms (2)

Esomeprazole

EXPERIMENTAL

High-dose esomeprazole

Drug: Esomeprazole

Pantoprazole

ACTIVE COMPARATOR

High-dose pantoprazole

Drug: Pantoprazole

Interventions

Esomeprazole DRUG

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

Also known as: Nexium

Esomeprazole

Pantoprazole DRUG

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

Also known as: Pantoloc

Pantoprazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lotung Poh-Ai Hospital: lead
• Tomorrow Medical Foundation: collaborator

Related Publications (1)

• 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.

  PMID: 19221370 BACKGROUND

MeSH Terms

Conditions

Peptic Ulcer; Peptic Ulcer Hemorrhage; Hemorrhage

Interventions

Esomeprazole; Pantoprazole

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hwai-Jeng Lin, M.D.

  Lotung Poh-Ai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 13, 2009
• First Posted: April 15, 2009
• Last Updated: April 8, 2015

Record last verified: 2009-04