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

The Chinese University of Hong Kong

Status and phase: Terminated; Phase 2

Conditions: Gastrointestinal Hemorrhage

Treatments: Drug: Intravenous bolus injection of esomeprazole; Drug: Oral esomeprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00164788

Ne_pH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 7 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

IV Nexium

Active Comparator group

Description:

Intravenous bolus injection of esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours

Treatment:

Drug: Intravenous bolus injection of esomeprazole

Oral Nexium

Active Comparator group

Description:

Oral esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 40mg every 12 hours for 24 hours

Treatment:

Drug: Oral esomeprazole