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

Phase 2

Terminated

• Conditions: Gastrointestinal Hemorrhage
• Interventions: Drug: Intravenous bolus injection of esomeprazole; Drug: Oral esomeprazole

• Registration Number: NCT00164788
• Lead Sponsor: Chinese University of Hong Kong

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-27
• Last Update Posted: 2012-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV Nexium	Intravenous bolus injection of esomeprazole	Intravenous bolus injection of esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 80mg followed by continuous intravenous infusion of 8mg per hour for 24 hours
Oral Nexium	Oral esomeprazole	Oral esomeprazole (Astra Pharmaceutica AG, Dietikon, Switzerland) 40mg every 12 hours for 24 hours

Primary Outcome Measures

Name	Time	Method
The primary measure of this study is the median gastric pH over 24-hour monitoring.	24 hours

Secondary Outcome Measures

Name	Time	Method
acid suppressing activity, notably the rate of onset of action, between the two treatment regimens: 1. Percentage time of pH<6 2. Time to reach pH 6 3. Median gastric pH in the first 6 and 12 hours	24 hours

Trial Locations

Locations (1)

Endoscopy Center, Prince of Wales Hospital; 🇨🇳 Hong Kong (SAR), China

Endoscopy Center, Prince of Wales Hospital

🇨🇳Hong Kong (SAR), China