A Comparison of Gastric pH Control With High Dose Intravenous or Oral Esomeprazole

• Status: Terminated
• Trial end date: 2011-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators hypothesize that high dose esomeprazole 80mg given as a bolus, followed by 8mg/h would render gastric pH near neutral and that pH control with esomeprazole given in such a high dose either intravenous or orally is identical.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Esomeprazole

Criteria

Inclusion Criteria:

• Patients admitted with diagnosis of upper gastrointestinal bleeding aged between 18 and 80

• Endoscopic confirmation of a bleeding duodenal or gastric ulcer to which endoscopic control has been obtained

• Absence of H. pylori infection

• Informed written consent

Exclusion Criteria:

• Known incompatibility to the study drugs;

• Known incompatibility and hypersensitivity to proton pump inhibitor

• H. pylori infection

• Recent H2RA or PPI use (within last 4 weeks)

• Concomitant use of medications that may interfere gastric acid secretion or motility (e.g. anticholinergic, metoclopramide, domperidone)

• Pregnancy or lactation;

• Non-compliance e.g. mental subordination

• Nasopharyngeal or oropharyngeal pathology that would prevent passage of a nasal catheter

• Significant liver disease as PPI is metabolized by the cytochrome P-450 system

• Previous gastric surgery

• Chronic Aspirin user

• Presence of esophageal/ gastric varices

• Moribund patients, terminal malignancy & patients with severe renal disease

• Patient unable to give written consent