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

A Randomized Comparison of High Dose Oral to Intravenous Esomeprazole in Patients After Endoscopic Control to Their Bleeding Peptic Ulcers: an Intra-gastric pH Study.

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.

Bleeding peptic ulcer is a common and life threatening condition. Endoscopic therapy has become the mainstay of controlling bleeding. Recurrent bleeding after endoscopic control occurs in about 20% of patients with a high associated mortality. We previously demonstrated that the adjunct use of high dose proton pump inhibitor reduces risk of recurrent bleeding and thereby improves patients' outcome [Lau JY N Engl J Med 2000]. The newer PPI, esomeprazole, is an S-isomer of omeprazole. Esomeprazole is more effective in gastric acid control as measured by both basal and pentagastrin acid output when compared to omeprazole. Esomeprazole when given orally at a lower dose achieves a similar gastric control than intravenous esomeprazole. The gastric pH with a high dose esomeprazole when given either orally or intravenously has not been measured among Hong Kong Chinese. If a high dose oral esomeprazole achieves a similar pH control near gastric neutrality, the oral regime can be used in place of the intravenous formulation. This represents significant convenience in dosing and cost savings.

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